Hydrelix 7-200-001

GUDID 00745713000014

1 gram Collagen Powder

Southwest Technologies, Inc.

Animal-derived wound matrix dressing

• Primary Device ID: 00745713000014
• NIH Device Record Key: c1481acf-c0d6-48da-a452-8d8a4012dfcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hydrelix
• Version Model Number: HDX001
• Catalog Number: 7-200-001
• Company DUNS: 048078018
• Company Name: Southwest Technologies, 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00745713000014 [Package]; Contains: 00745713000021; Package: Case [10 Units]; In Commercial Distribution
GS1	00745713000021 [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: 2025-09-19
• Device Publish Date: 2025-09-11

On-Brand Devices [Hydrelix]

• 00745713000045: 5 gram Collagen Powder
• 00745713000014: 1 gram Collagen Powder