AccessGUDID - DEVICE: PriMatrix® (10381780113416)

GUDID

Device Identifier (DI) Information

Brand Name: PriMatrix®
Version or Model: 607-005-220
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 607-005-220
Company Name: TEI BIOSCIENCES INC.

Primary DI Number: 10381780113416
Issuing Agency: GS1
Commercial Distribution End Date: October 21, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 796253292 *Terms of Use

Device Description: PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	DRESSING, WOUND, COLLAGEN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131286	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2 x 2 x (0.20 - 1.04) cm x cm x mm

Device Record Status

Public Device Record Key: 641d5330-3353-44b3-85cb-6aff06020429
Public Version Date: July 21, 2025
Public Version Number: 5
DI Record Publish Date: October 21, 2015