AccessGUDID - DEVICE: PriMatrix® (10381780113652)

GUDID

Device Identifier (DI) Information

Brand Name: PriMatrix®
Version or Model: 6495-9-104
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6495-9-104
Company Name: TEI BIOSCIENCES INC.

Primary DI Number: 10381780113652
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2016
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	Collagen wound matrix dressing	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	DRESSING, WOUND, COLLAGEN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153690	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 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 4 x 4 x (0.20 - 1.04) cm x cm x mm

Device Record Status

Public Device Record Key: 7e197fe5-14eb-494c-a4ff-2966484cce2c
Public Version Date: January 17, 2024
Public Version Number: 8
DI Record Publish Date: October 21, 2015