AccessGUDID - DEVICE: PriMatrix® Ag (10381780113591)

GUDID

Device Identifier (DI) Information

Brand Name: PriMatrix® Ag
Version or Model: 607-105-125
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 607-105-125
Company Name: TEI BIOSCIENCES INC.

Primary DI Number: 10381780113591
Issuing Agency: GS1
Commercial Distribution End Date: February 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 796253292 *Terms of Use

Device Description: PriMatrix® Ag Meshed Antimicrobial Dermal Repair Scaffold 10 cm x 25 cm

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
FRO	Dressing, wound, drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100261	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: 10 x 25 x (0.20 - 1.04) cm x cm x mm

Device Record Status

Public Device Record Key: 88503dfd-add2-4b28-958b-27beeee177ad
Public Version Date: June 05, 2023
Public Version Number: 8
DI Record Publish Date: October 14, 2015