FDA.reportPublic FDA data

PriMatrix®

Primary DI
10381780545385
Brand
PriMatrix®
Company
INTEGRA LIFESCIENCES
Model
607-005-812
Catalog number
607-005-812
Device description
PriMatrix® Dermal Scaffold 8 cm x 12 cm
Published
2026-01-12
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

Contact Domains#

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
K250397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250397000Helios Dermal ScaffoldHelios Biomedical, Inc.2025-08-15KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780113478PreviousGS10
10381780545385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011347810381780113478
1038178054538510381780545385

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Centimeter
Width12Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
016419552
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780545316PriMatrix®607-005-018607-005-0182026-01-12
10381780545323PriMatrix®607-005-220607-005-2202026-01-12
10381780545330PriMatrix®607-005-330607-005-3302026-01-12
10381780545347PriMatrix®607-005-440607-005-4402026-01-12
10381780545354PriMatrix®607-005-550607-005-5502026-01-12
10381780545361PriMatrix®607-005-660607-005-6602026-01-12
10381780545378PriMatrix®607-005-880607-005-8802026-01-12
10381780545392PriMatrix®607-001-112607-001-1122026-01-12
10381780545408PriMatrix®607-005-125607-005-1252026-01-12
10381780545415PriMatrix®607-005-225607-005-2252026-01-12
10381780545576PriMatrix®607-001-440607-001-4402026-01-12
10381780545583PriMatrix®607-004-440607-004-4402026-01-12
10381780545590PriMatrix®607-001-660607-001-6602026-01-12
10381780545606PriMatrix®607-004-660607-004-6602026-01-12
10381780545613PriMatrix®607-001-880607-001-8802026-01-12
10381780545620PriMatrix®607-004-880607-004-8802026-01-12
10381780545637PriMatrix®607-001-812607-001-8122026-01-12
10381780545644PriMatrix®607-001-125607-001-1252026-01-12
10381780545651PriMatrix®607-001-225607-001-2252026-01-12
10381780545569PriMatrix®607-005-014607-005-0142026-03-04

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