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510(k) Data Aggregation
K Number
K971832Device Name
IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC, IVALON EYE WICK
Manufacturer
M-PACT WORLDWIDE MANAGEMENT CORP.
Date Cleared
1997-07-31
(73 days)
Product Code
HOZ
Regulation Number
886.4790Why did this record match?
Applicant Name (Manufacturer) :
M-PACT WORLDWIDE MANAGEMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ivalon® Eye Drain 80cc, Eye Drain 400cc, Surgical Spears, and Eye Wick 8-inch are used to absorb fluids from the operative field in ophthalmic surgery.
Device Description
The Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are packaged individually as a sterile, dried and compressed sponge. They are used to absorb fluids from the operative field in ophthalmic surgery. M-PACT Eye Drain 80cc, Eye Drain 400cc, Eye Wick 8-inch, and Surgical Spears are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde.
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K Number
K971473Device Name
IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
Manufacturer
M-PACT WORLDWIDE MANAGEMENT CORP.
Date Cleared
1997-07-07
(75 days)
Product Code
GEC, GER
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
M-PACT WORLDWIDE MANAGEMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ivalon® Instrument Wipe and PVA Knife Cleaning Block are used to clean surgical instruments and knives.
Device Description
Not Found
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K Number
K964113Device Name
IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL
Manufacturer
M-PACT WORLDWIDE MANAGEMENT CORP.
Date Cleared
1996-11-07
(23 days)
Product Code
EMX
Regulation Number
874.4100Why did this record match?
Applicant Name (Manufacturer) :
M-PACT WORLDWIDE MANAGEMENT CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nasal and sinus packings are used to absorb excess body fluids after septal, turbinate, or rhinoplastic surgery or endoscopic sinus surgery, and for the control of epistaxis (i.e., nose bleeds). Thev are packaged individually as a sterile, dried and compressed sponge that is inserted into the nasal or sinus cavity. When expanded via absorption of blood after insertion, the nasal packing is intended to fill the necessary space to prevent lateral motion of the turbinate and provide gentle pressure on the mucosa. The sinus packing is intended to selectively pack only the ostiomeatal complex leaving the nasal cavity clear for breathing.
Device Description
M-PACT nasal and sinus packings are made from formalized PVA sponge, which is a condensation product of polyvinyl alcohol and formaldehyde. Once the chemical reaction has taken place and the foam sponge has cured, the material is washed clean of any residual chemicals.
M-PACT's nasal and sinus products will be sold in different configurations with drawstrings and with and without airway tubes. The products will be provided sterile via gamma radiation in industry standard Tyvek/film and metalized polyester peelable pouches.
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