FDA.reportPublic FDA data

NIVIS

Primary DI
00813954024721
Brand
NIVIS
Company
COLLAGEN MATRIX, INC.
Model
FCWD20
Device description
Fibrillar Collagen Pack
Published
2022-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00813954024721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813954024721008139540247218139540247210813954024721

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176262442
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813954028767Gibson Healthcare Alloplast6247-9926247-9922026-05-26
00813954028774Gibson Healthcare Alloplast6248-0086248-0082026-05-26
00813954028781Gibson Healthcare Alloplast6248-0176248-0172026-05-26
00813954028873PuraKOTE+PGKTE+PGKTE+2026-05-26
00813954028880PuraPLUG+PGPLG+PGPLG+2026-05-26
00813954028897PuraTAPE+PGTPE+PGTPE+2026-05-26
00813954028385collatene509101050910102026-05-05
00813954028620AmpliDermAMPLIDERM-ROUND-10AMPLIDERM-ROUND-102026-04-06
00813954028637AmpliDermAMPLIDERM-THICK-15X20AMPLIDERM-THICK-15X202026-04-06
00813954028644AmpliDermAMPLIDERM-THICK-20X30AMPLIDERM-THICK-20X302026-04-06
00813954028651AmpliDermAMPLIDERM-THICK-30X40AMPLIDERM-THICK-30X402026-04-06
00813954028668AmpliDermAMPLIDERM-THIN-15X20AMPLIDERM-THIN-15X202026-04-06
00813954028675AmpliDermAMPLIDERM-THIN-20X30AMPLIDERM-THIN-20X302026-04-06
00813954028682AmpliDermAMPLIDERM-THIN-30X40AMPLIDERM-THIN-30X402026-04-06
00813954028590bioMAINTAINOUSA1EUOUSA1EU2026-03-23
00813954028606bioMAINTAINOUSA2EUOUSA2EU2026-03-23
00813954028613bioMAINTAINOUSA3EUOUSA3EU2026-03-23
00813954028736SALVIN OraCOTE+ORACOTE-PLUS-PKG-10ORACOTE-PLUS-PKG-102026-03-18
00813954028743SALVIN OraPLUG+ORAPLUG-PLUS-PKG-10ORAPLUG-PLUS-PKG-102026-03-18
00813954028750SALVIN OraTAPE+ORATAPE-PLUS-PKG-10ORATAPE-PLUS-PKG-102026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813954028385collateneCOLLAGEN MATRIX, INC.KGN2026-05-05
10840330705858ProCureTwin Med, LLCKGN2026-05-04
10840330705834ProCureTwin Med, LLCKGN2026-04-28
10840330705841ProCureTwin Med, LLCKGN2026-04-28
00812593023119NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023126NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023072NeoSurg Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023089ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023096ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023102ColSyntekBiogennix, LLCKGN2026-04-22
10885632434280HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
10885632434297HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
00324357900012Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00324357900777Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00812593023058Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023065Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023034CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
00812593023041CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
10885632434273HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-03-31
16942327004853DimoraWinner Medical Co., Ltd.KGN2026-03-30
16942327019628DimoraWinner Medical Co., Ltd.KGN2026-03-30
16942327050027DimoraWinner Medical Co., Ltd.KGN2026-03-30
00813954028736SALVIN OraCOTE+COLLAGEN MATRIX, INC.KGN2026-03-18
00813954028743SALVIN OraPLUG+COLLAGEN MATRIX, INC.KGN2026-03-18
00813954028750SALVIN OraTAPE+COLLAGEN MATRIX, INC.KGN2026-03-18
10888277720725MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
10888277720732MEDLINEMEDLINE INDUSTRIES, INC.KGN2026-03-10
00813954028439Tissue Specialists Resorbable Collagen PlugCOLLAGEN MATRIX, INC.KGN2026-03-09
00813954028446Tissue Specialists Resorbable Collagen TapeCOLLAGEN MATRIX, INC.KGN2026-03-09
00813954028545bioSTRIPCOLLAGEN MATRIX, INC.KGN2026-03-09