BioCol 8-050-002

GUDID 00745713086025

5 gram Collagen Powder

Southwest Technologies, Inc.

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 00745713086025
• NIH Device Record Key: 7f3b9b61-9efe-4171-833d-28474b728b7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioCol
• Version Model Number: AWC02
• Catalog Number: 8-050-002
• Company DUNS: 048078018
• Company Name: Southwest Technologies, Inc.
• Device Count: 15
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com
• Phone: +1(800)247-9951
• Email: quality@elastogel.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00745713086025 [Unit of Use]
GS1	00745713186022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030774

FDA Product Code

• KGN: Wound dressing with animal-derived material(s)

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: 2023-03-01
• Device Publish Date: 2023-02-21

On-Brand Devices [BioCol]

• 00745713086025: 5 gram Collagen Powder
• 00745713086018: 1 gram Collagen Powder