FDA.reportPublic FDA data

COL-FID4 Care Collagen Wound Dressing

Primary DI
M713COL2021
Brand
COL-FID4 Care Collagen Wound Dressing
Company
FIDIA FARMACEUTICI SPA
Model
COL202
Catalog number
COL202
Device description
COL-FID 4 CARE Collagen is a native 100% Bovine Type 1 collagen, which when applied to a wound surface, absorbs wound exudate, and maintains a moist wound environment to aid in the management of wound healing. COL-FID 4 Care Collagen Dressing may be used in the management of partial and full thickness wounds,pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, cuts, and abrasions. Each carton contains 5 dressings and each case contains 10 cartons.
Published
2025-11-24
Public version status
New
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
KGNWound Dressing With Animal-Derived Material(S)

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
M713COL20201PackageHIBCC5In Commercial Distribution
M713COL2021PrimaryHIBCC0
M713COL2020Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.

Regulatory Flags#

DUNS number
428453013
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M71389122179604A15HYALO GYN Vaginal Hydrating Gel, 30g Tube1796041796042016-11-01
M7131797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens1797041797042021-03-25
M7133797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens Sample3797043797042021-03-25
M713891220750010HYMOVIS® ONE 32mg/4ml syringe89122-0750-0189122-0750-012025-11-07
M713FID075010HYMOVIS® ONE Professional Sample, 32mg/4ml syringeFID07501FID075012025-11-07
M713FPRP400RICHPLAT ORTHO 40 PRP SYSTEMFPRP40FPRP402025-10-31
M713FPRP200RICHPLAT ORTHO PRP SYSTEMFPRP20FPRP202021-03-25
M71389122072412A1Hyalgan® Sodium Hyaluronate 2mL Vial89122-0724-1289122-0724-122015-07-31
M71389122087901A1TriLURONM71389122087901A1389122-0879-012019-11-04
M71389122072420A1Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL89122-0724-2089122-0724-202015-07-31
M713891220879010TRILURON89122-0879-0189122-0879-012024-05-07
M713891220724200Hyalgan® Sodium Hylauronate Pre-filled Syringe - 2mL89122-0724-2089122-0724-202023-10-16
M713891220724120Hyalgan® Sodium Hyaluronate 2mL Vial89122-0724-1289122-0724-122023-09-13
M71389122049663A16Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe89122-0496-6389122-0496-632016-03-21
M713494290030100Hyalo4 Care Clear Hydrogel, 30g49429-0030-1049429-0030-102023-06-14
M713494290100350Hyalo4 Care Clear Hydrogel, 100g49429-0100-3549429-0100-352023-06-14
M713494440025080Hyalo4 Care Hydrogel, 25g49444-0025-0849444-0025-082023-06-14
M713494440100350Hyalo4 Care Hydrogel, 100g49444-0100-3549444-0100-352023-06-14
M713100004050HYALO GYN Vaginal Moisturizing Suppositories Sample10000405100004052021-03-25
M713891220496010Hymovis® High Molecular Weight Viscoelastic Hyaluronan, 24mg/3ml syringe, 1 pack89122-0496-0189122-0496-012022-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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