Keramatrix KM-1010

GUDID 00850072068886

Biowound Solutions, Inc.

Keratin dressing

• Primary Device ID: 00850072068886
• NIH Device Record Key: d42c23cd-9c4e-4f42-b189-c2ce3fb30067
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Keramatrix
• Version Model Number: KM-1010
• Catalog Number: KM-1010
• Company DUNS: 135705894
• Company Name: Biowound Solutions, Inc.
• Device Count: 1
• DM Exempt: false
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850072068886 [Primary]

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: 2025-06-26
• Device Publish Date: 2025-06-18

On-Brand Devices [Keramatrix]

• 00850072068886: KM-1010
• 00850072068879: KM-0505
• 00850072068862: KM-0203