3M™ Promogran™

Basic Information

• Brand Name: 3M™ Promogran™
• Primary DI: 04054596956360
• Version / Model: PG004
• Catalog Number: PG004
• Company Name: 3M Deutschland GmbH
• Labeler DUNS: 315731711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-12-06
• Public Version: 1
• Public Version Date: 2023-12-14
• Public Version Status: New
• Public Device Record Key: 4a952578-7c8c-4fad-99cb-4e8c7232ab1e

Device Description

3M™ Promogran™ Collagen Matrix with ORC, PG004, Hexagon 28 cm2 (4.34 sq in), 10/Ct, 4 Cts/Cs

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: No
• 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	04054596956377	GS1	BOX	4	In Commercial Distribution
Primary	04054596956360	GS1
Unit of Use	04054596956353	GS1

Customer Contacts

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