Endoform™ Antimicrobial Restorative Bioscaffold

Basic Information

• Brand Name: Endoform™ Antimicrobial Restorative Bioscaffold
• Primary DI: 09421906017489
• Version / Model: 629313
• Company Name: AROA BIOSURGERY LIMITED
• Labeler DUNS: 594540572
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-20
• Public Version: 3
• Public Version Date: 2025-07-21
• Public Version Status: Update
• Public Device Record Key: bf25852b-a34a-49d8-a673-1807cebba409

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

• 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: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Package	09421906017557	GS1	Carton	10	In Commercial Distribution
Primary	09421906017489	GS1

Premarket Submissions

Submission Number	Supplement Number
K172318	000

Device Sizes

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Endoform Antimicrobial should be stored at room temperature in a clean and dry area, away from direct light.