Solventum™ Promogran™ PG004V003

GUDID 00197998275364

Solventum™ Promogran™ Collagen Matrix with ORC, PG004, Hexagon, 4.34 in2 (28 cm2), 10/CAR, 4 CAR/CS, 40/CS

Solventum US LLC

Animal-derived wound matrix dressing

• Primary Device ID: 00197998275364
• NIH Device Record Key: 7926fa9b-ec33-44d1-8bc7-1f11a76a75d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solventum™ Promogran™
• Version Model Number: PG004V003
• Catalog Number: PG004V003
• Company DUNS: 119004140
• Company Name: Solventum US LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com
• Phone: +1(800)228-3957
• Email: regulatoryrequests@solventum.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197998275340 [Primary]
GS1	00197998275364 [Package]; Contains: 00197998275340; Package: CASE [40 Units]; In Commercial Distribution

FDA Product Code

• FRO: Dressing, wound, drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [Solventum™ Promogran™]

• 00197998275524: Solventum™ Promogran™ Collagen Matrix with ORC, M772123, Hexagon, 19.1 in2 (123 cm2), 10/CAR
• 00197998275401: Solventum™ Promogran™ Collagen Matrix with ORC, PG019, Hexagon, 19.1 in2 (123 cm2), 10/CAR,
• 00197998275364: Solventum™ Promogran™ Collagen Matrix with ORC, PG004, Hexagon, 4.34 in2 (28 cm2), 10/CAR, 4
• 00197998175251: Solventum™ Promogran™ Collagen Matrix with ORC, M772028, 4.34 in2 (28 cm2), Hexagon, 10/CAR,