Endoform Antimicrobial Dermal Template

Basic Information

• Brand Name: Endoform Antimicrobial Dermal Template
• Primary DI: 09421904065444
• Version / Model: 629312
• Catalog Number: 629312
• Company Name: AROA BIOSURGERY LIMITED
• Labeler DUNS: 594540572
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-31
• Public Version: 5
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: ebfd497a-32d1-4d55-b81f-2826929ddea9

Device Description

Endoform Antimicrobial Dermal Template is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	09421904065604	GS1	SHIPPER	100	In Commercial Distribution
Package	09421904065543	GS1	CARTON	10	In Commercial Distribution
Primary	09421904065444	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172318	000

Device Sizes

Type	Value	Unit	Text
Width	5	Centimeter
Length	5	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: clean and dry area, away from direct light