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Found 9 results
510(k) Data Aggregation
K Number
K992732Device Name
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
2000-04-20
(251 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- For Irrigation of Medical Device Only .
- Not for Injection or Flushing of Skin Tissues .
Device Description
Not Found
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K Number
K993119Device Name
STERILE HYDROGEL
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1999-11-23
(64 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hydrogel sterile dressing is for the wound management of partial and full thickness pressure ulcer, stasis ulcers, first & second degree burns, cuts, abrasions, irritations of the skin and skin condition associated with periostomal care.
Device Description
Sterile Hydrogel
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K Number
K990332Device Name
DUMEX IODOFORM PACKING STRIP
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1999-04-14
(70 days)
Product Code
FRO, MXI
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FOR GENERAL USE - DN AS DRADABADA No 2 WOND AACK WOUND MANAGEMENT CONDUIT IN
Device Description
Not Found
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K Number
K980779Device Name
THALAFIX NATURAL SEA SALT DRESSING
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1998-06-26
(116 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications: minor cuts, minor burns and minor lacerations. Under the guidance of a health care professional, the Thalafix Natural Sea-Salt Dressing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.
Device Description
The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt.
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K Number
K980861Device Name
DUMEX PAK-ITS COTTON GAUZE PACKING IMPREGNATED WITH HYDROGEL
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1998-05-20
(76 days)
Product Code
MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hydrogel dressing is intended for use to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment around the wound. The dressing is appropriate applied to the following indications: minor cuts, minor lacerations. Under the guidance of a health professional the hydrogel dressing is also indicated for surgical incisions and excisions, venous stasis ulcers and decubitus ulcers.
Device Description
Dumex Pak-its Cotton Gauze Packing Impregnated with Hydrogel
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K Number
K980863Device Name
DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1998-05-11
(67 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-Woven dressing impregnated with Sodium Chloride is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to the wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications:minor cuts, minor burns and minor lacerations. Under the guidance of a heatth care professional, "AbsorbaSalt" Cotton Gauze Packing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.
Device Description
Dumex Pak-its Non-Woven Dressing Impregnated with Sodium Chloride
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K Number
K980777Device Name
DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1998-05-04
(63 days)
Product Code
FRO, MGP
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "AbsorbaSalt" Cotton Gauze Packing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will Sur that is mondou for act on moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the dressing is appropriate would offications will our cuts, minor burns and minor lacerations. Under the guidance for the following multions: himor outs, rather attern Gauze Packing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.
Device Description
The "AbsorbaSalt" Cotton Gauze Packing is a dry dressing impregnated with crystalline seawater salt.
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K Number
K980791Device Name
DUMEX PAK-ITS WOVEN RIBBON PACKING
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1998-04-29
(58 days)
Product Code
EFQ, EFO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dumex Pak-its-Woven Ribbon Packing is intended to absorb exudate from discharging wounds into a secondary dressing. The packing is indicated for the following exudating wounds: minor cuts, abrasions and incisions. The packing may also be used on infected wounds under the care of a health care professional.
Device Description
Not Found
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K Number
K960815Device Name
DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL
Manufacturer
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
Date Cleared
1996-04-29
(61 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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