FDA.reportPublic FDA data

PriMatrix® Ag

Primary DI
10381780113768
Brand
PriMatrix® Ag
Company
TEI BIOSCIENCES INC.
Model
607-104-812
Device description
PriMatrix® Ag Fenestrated 8 x 12 cm
Published
2016-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100261000PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLDTei Biosciences, Inc.2010-12-10FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780113768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178011376810381780113768

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796253292
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780540762Durepair™62106621062025-01-31
10381780540823Durepair™62110621102025-01-31
10381780540786Durepair™62158621582025-01-31
10381780540854Durepair™62100621002025-01-31
10381780540878Durepair™62111621112025-01-31
10381780540892Durepair™62105621052025-01-31
10381780113317PriMatrix®607-001-125607-001-1252015-10-21
10381780113294PriMatrix®607-001-009607-001-0092015-10-21
10381780113300PriMatrix®607-001-112607-001-1122015-10-21
10381780113324PriMatrix®607-001-225607-001-2252015-10-21
10381780113331PriMatrix®607-001-440607-001-4402015-10-21
10381780113348PriMatrix®607-001-660607-001-6602015-10-21
10381780113355PriMatrix®607-001-812607-001-8122015-10-21
10381780113362PriMatrix®607-001-880607-001-8802015-10-21
10381780113379PriMatrix®607-004-440607-004-4402015-10-21
10381780113386PriMatrix®607-004-660607-004-6602015-10-21
10381780113393PriMatrix®607-004-880607-004-8802015-10-21
10381780113409PriMatrix®607-005-125607-005-1252015-10-23
10381780113416PriMatrix®607-005-220607-005-2202015-10-21
10381780113423PriMatrix®607-005-225607-005-2252015-10-21

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Primary DI, Brand, Company table
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00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990802Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990895Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
10884389161562MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-06
00361470000175Amerigel Saline Wound WashAmerx Health Care Corp.FRO2026-06-22
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08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
00850087488266CeeportCEEPORT INC.FRO2026-05-29
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27