Solventum™ Promogran™

Basic Information

• Brand Name: Solventum™ Promogran™
• Primary DI: 00197998275388
• Version / Model: PG019
• Catalog Number: PG019
• Company Name: Solventum Germany GmbH
• Labeler DUNS: 315518329
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-22
• Public Version: 4
• Public Version Date: 2026-03-20
• Public Version Status: Update
• Public Device Record Key: edce56c9-4dfc-4604-8663-bdfe8a1c0072

Device Description

Solventum™ Promogran™ Collagen Matrix with ORC, PG019, Hexagon, 19.1 in2 (123 cm2), 10/CAR, 4 CAR/CS, 40/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: Yes
• 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
KGN	Wound dressing with animal-derived material(s)	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	00197998275401	GS1	CASE	40	In Commercial Distribution
Primary	00197998275388	GS1

Customer Contacts

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