FDA.report

V.A.C.® GRANUFOAM™ Silver™

Primary DI
00849554002500
Brand
V.A.C.® GRANUFOAM™ Silver™
Company
KCI USA, INC.
Model
M8275099/5 M8275099/10
Device description
Vac Granufoam Silver Dressing Large Featuring Sensatrac Technology
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications

CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849554000919PackageGS15In Commercial Distribution
00849554000926PackageGS110In Commercial Distribution
00849554002500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849554000919008495540009198495540009190849554000919
00849554000926008495540009268495540009260849554000926
00849554002500008495540025008495540025000849554002500

GMDN Terms

TermDefinition
Negative-pressure wound therapy system foam dressing, antimicrobialA pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT), and that contains an antimicrobial agent [e.g., silver (Ag)]. It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
102726734
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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