Search Results
Found 38 results
510(k) Data Aggregation
K Number
K991757Device Name
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
Manufacturer
FURLONG INDUSTRIES
Date Cleared
1999-08-12
(80 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Product Code :
EFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices, both sterile and non sterile, are indicated for external use only and are intended to be used to clean wounds, to scrub or prepare incision sites, to absorb fluids, and dress wounds.
Device Description
Furlong Industries' Non-X-Ray Detectable Gauze Sponges/Bandages, both sterile and non sterile, consist of cotton, rayon or rayon/polyester formed material and/or cellulose. This device is for externation of conly for cleaning wounds, scrubbing, dressing and fluid absorption.
Ask a Question
K Number
K991215Device Name
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
Manufacturer
SYMTEX HEALTHCARE CORP.
Date Cleared
1999-06-11
(63 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Product Code :
EFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THIS PRODUCT IS INTENDED TO BE USED BY:
- SURGEONS
• NURSES
• LAB TECHNICIANS
• I. V. TEAM
FOR THE FOLLOWING PROCEDURES:
• WOUND DRESSING
• DEBRIDEMENT
• CLEANING
• PREPPING AND SCRUBBING
Device Description
Not Found
Ask a Question
K Number
K990974Device Name
VITOP DRESSING
Manufacturer
WONDER & BIOENERGY HI-TECH AMERICA, INC.
Date Cleared
1999-06-09
(78 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Product Code :
EFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Management of venous cuts, for example, cuts resulting from any shape objects and abrasions, other superficial injuries, superficial wounds, burns (1st and 2nd degree) donor sites, post operative wound.
Device Description
vitop® Dressing
Ask a Question
K Number
K990584Device Name
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
Manufacturer
BROADLINE MEDICAL INDUSTRIES
Date Cleared
1999-04-23
(59 days)
Product Code
EFQ, EFO
Regulation Number
N/AWhy did this record match?
Product Code :
EFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended uses of gauze sponges are absorption of blood and body fluids, wound dressing, prepping and scrubbing, and debridement. This product is patient contacting material.
Device Description
GAUZE SPONGES
Ask a Question
K Number
K984187Device Name
CROSSTEX NON-WOVEN SPONGES
Manufacturer
CROSSTEX INTL.
Date Cleared
1999-02-18
(87 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Product Code :
EFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Crosstex Non-Woven Sponges are intended, for medical purposes, to be placed directly on a patient's wound or burn to absorb excess body fluids or exudate.
Device Description
The Crosstex Non-Woven Sponges consist of non-woven materials quarter folded into:
- 2 X 2" (light) 4-Ply
- 2 X 2" (light)
- 3 X 3" (Premium) 4-Ply
- 4 X 4" (Premium) 4-Ply
sponges used for the absorption of liquids from the patient's skin.
Ask a Question
K Number
K983016Device Name
GAUZE, SPONGES, CAT # 11-003
Manufacturer
VITALCARE GROUP, INC.
Date Cleared
1999-02-12
(168 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Product Code :
EFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wound cover for patient care.
Device Description
Gauze, Sponges Various Sizes, Non-Sterile and Sterile
Ask a Question
K Number
K983348Device Name
DYNAREX TRACHEOSTOMY SPONGE
Manufacturer
DYNAREX CORP.
Date Cleared
1998-12-11
(79 days)
Product Code
EFQ, EFO
Regulation Number
N/AWhy did this record match?
Product Code :
EFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids.
Device Description
Tracheostomy Sponge
Ask a Question
K Number
K983450Device Name
STARRYSHINE GAUZE SPONGE
Manufacturer
T.C. DENTAL PRODUCTS, INC.
Date Cleared
1998-11-12
(43 days)
Product Code
EFQ
Regulation Number
N/AWhy did this record match?
Product Code :
EFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STARRYSHINE Gauze Sponges are intended for use to control bleeding, absorb body fluid, and protect wounds from contamination
Device Description
STARRYSHINE GAUZE SPONGE Are composed of USP type VII gauze, available in the thickness of 8 ply (2" x 2") 4 ply (2" x 2"), it's non-sterile and made with 100% cotton.use in control bleeding, absorb body fluids and protect wounds from contamination.
Ask a Question
K Number
K982648Device Name
JOAN II
Manufacturer
CELANESE ACETATE CO.
Date Cleared
1998-09-30
(63 days)
Product Code
EFQ, EFO
Regulation Number
N/AWhy did this record match?
Product Code :
EFQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JoAn II ™ is designed for external application for use in absorbing fluids.
Device Description
Not Found
Ask a Question
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?
Product Code :
EFQ
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
Ask a Question
Page 1 of 4