FDA.reportPublic FDA data

InnovaMatrix FS

Primary DI
00850002643343
Brand
InnovaMatrix FS
Company
Triad Life Sciences, Inc.
Model
IMF-0404-01
Catalog number
IMF-0404-01
Device description
4cm x 4cm Fenestrated Placental ECM
Published
2022-12-20
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210580000InnovaMatrix FSTriad Life Sciences, Inc.2021-04-21KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002643343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002643343008500026433438500026433430850002643343

GMDN Terms#

Term, Definition table
TermDefinition
Wound compression dressingA sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.

Regulatory Flags#

DUNS number
081037338
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002643411InnovaMatrix ACIMX-18MM-012025-01-09
00850002643428InnovaMatrix ACIMX-0203-012025-01-09
00850002643435InnovaMatrix ACIMX-0304-012025-01-09
00850002643442InnovaBurnIMB-0606-012025-01-09
00850002643459InnovaBurnIMB-0707-012025-01-09
00850002643466InnovaBurnIMB-0810-012025-01-09
00850002643473InnovaBurnIMB-1012-012025-01-09
00850002643480InnovaMatrix FSIMF-0203-012025-01-09
00850002643497InnovaMatrix FSIMF-0304-012025-01-09
00850002643503InnovaMatrix FSIMF-0406-012025-01-09
00850002643268InnovaBurnIMB-0505-01IMB-0505-012022-12-21
00850002643275InnovaBurnIMB-0507-01OMB-0507-012022-12-21
00850002643282InnovaBurnIMB-0808-01IMB-0808-012022-12-21
00850002643299InnovaBurnIMB-1010-01IMB-1010-012022-12-21
00850002643305InnovaBurnIMB-1020-01IMB-1020-012022-12-21
00850002643312InnovaBurnIMB-1520-01IMB-1520-012022-12-21
00850002643367InnovaMatrix PDIMP-0050-01IMP-0050-012022-12-21
00850002643374InnovaMatrix PDIMP-0100-01IMP-0100-012022-12-21
00850002643398InnovaMatrix PDIMP-0250-01IMP-0250-012022-12-21
00850002643404InnovaMatrix PDIMP-0500-01IMP-0500-012022-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02
00850084084034CURCOFR TECH, LLCKGN2026-06-02
00850084084041CURCOFR TECH, LLCKGN2026-06-02
00850084084058CURCOFR TECH, LLCKGN2026-06-02
00850084084065CURCOFR TECH, LLCKGN2026-06-02
00850084084072CURCOFR TECH, LLCKGN2026-06-02
00850084084089CURCOFR TECH, LLCKGN2026-06-02
00714196003317DermaCol 100 Gel 1oz TubeSion Brands LLCKGN2026-06-01
07610221017737Derma-Gide®Geistlich Pharma AGKGN2026-06-01
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