AccessGUDID - DEVICE: Endoform™ Antimicrobial Restorative Bioscaffold (09421906017434)

GUDID

Device Identifier (DI) Information

Brand Name: Endoform™ Antimicrobial Restorative Bioscaffold
Version or Model: 629304
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AROA BIOSURGERY LIMITED

Primary DI Number: 09421906017434
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 594540572 *Terms of Use

Device Description: Endoform™ Antimicrobial is a 100% w/w intact extracellular matrix (ECM), manufactured from ovine (sheep) forestomach tissue and incorporating approximately 12 ug/cm2 (~0.3% w/w) ionic silver, intended to inhibit colonization of the device. This advanced wound care device retains the innate biological structure of the native ECM, along with associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. When rehydrated with exudate or sterile saline, Endoform Antimicrobial transforms into a soft conforming sheet, which is naturally incorporated into the wound over time.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
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 [?]
K172318	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
Special Storage Condition, Specify: Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 x 12.7 cm - 4 x 5"

Device Record Status

Public Device Record Key: cc7ced7b-fe86-42ae-b2bc-5b8febcb4b1f
Public Version Date: April 09, 2025
Public Version Number: 2
DI Record Publish Date: August 20, 2021