FDA.reportPublic FDA data

Zimmer Collagen Patch

Primary DI
00813954020440
Brand
Zimmer Collagen Patch
Company
COLLAGEN MATRIX, INC.
Model
0101Z
Device description
Absorbable Wound Dressing 2cm x 4cm.
Published
2015-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813954020440PrimaryGS10
M4400101Z1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954020440008139540204408139540204400813954020440

GMDN Terms#

Term, Definition table
TermDefinition
General oral wound dressing, animal-derivedA collagen protein matrix derived from animal products (e.g., porcine, bovine) intended to be used as a protective cover for the general oral mucosa to manage wounds and sores in the mouth such as ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds; it may in addition, or alternatively, be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis. It may be supplied in various forms (e.g., gel, paste, fluid, water/oil spray solution) for use in the home or a clinical setting. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
176262442
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813954020433Zimmer Collagen Tape0100Z2015-10-23
00813954020457Zimmer Collagen Plug0102Z2015-10-23
00813954029078PLENA FLEXCDMPP3040CDMPP30402026-10-13
00813954029085PLENA MEDIUMPDM3040PDM30402026-10-13
00813954021065AugmatrixM600-020-102015-10-23
00813954021072AugmatrixM600-040-102015-10-23
00813954021089AugmatrixM610-050-102015-10-23
00813954021096AugmatrixM610-100-102015-10-23
00813954021102AugmatrixM630-100-102015-10-23
00813954021119AugmatrixM630-200-102015-10-23
00813954021126AugmatrixM620-020-102015-10-23
00813954021133AugmatrixM620-050-102015-10-23
00813954021140AugmatrixM620-100-102015-10-23
00813954021157AugmatrixM640-120-102015-10-23
00813954028798Dyna-Bone Plug10.905.062510.905.06252026-07-02
00813954028804Dyna-Bone Plug10.905.102010.905.10202026-07-02
M440SGG0500StarGraft GranulesSGG0502015-10-23
M440SGG1000StarGraft GranulesSGG1002015-10-23
M440SGG2000StarGraft GranulesSGG2002015-10-23
M440SGG3500StarGraft GranulesSGG3502015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610221017621DermaFormGeistlich Pharma AGKGN2026-10-19
00810226442979Vive CareVIVE HEALTH LLCKGN2026-10-14
00850083365035LaviorLavior Pharma Inc.KGN2026-10-08
00850083365042LaviorLavior Pharma Inc.KGN2026-10-08
00850083365059LaviorLavior Pharma Inc.KGN2026-10-08
00850065122236VitaleCELLERA LLCKGN2026-10-01
00850088144963CARBOUNingbo kehu Medical Technology Co.,Ltd.KGN2026-09-30
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969505MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31