BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

PriMatrix® Ag

DI: 10381780177685 · Model: 607-105-112 · TEI BIOSCIENCES INC.

View on AccessGUDID

Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: PriMatrix® Ag
Primary DI: 10381780177685
Version / Model: 607-105-112
Company Name: TEI BIOSCIENCES INC.
Labeler DUNS: 796253292
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-06-22
Public Version: 6
Public Version Date: 2025-07-21
Public Version Status: Update
Public Device Record Key: 62f77087-0596-45a1-b7e3-dbc71326efdc

Device Description

PriMatrix® Ag 2:1 Meshed 10 x 12 cm

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Safe
Direct Marking Exempt: Yes
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Animal-derived wound matrix dressing	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780177685	GS1

Customer Contacts

Phone: +1(800)654-2873
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100261	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1 x 12 x (0.40 - 1.04) cm x cm x mm

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 15 – 30 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: 59 – 86 Degrees Fahrenheit
Type: Handling Environment Temperature
Temperature Range: 15 – 30 Degrees Celsius
Type: Handling Environment Temperature
Temperature Range: 59 – 86 Degrees Fahrenheit