Elasto-Gel 2-025-002

GUDID 00745713486009

6" x 8" Sterile Wound Dressing

Southwest Technologies, Inc.

Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00745713486009
• NIH Device Record Key: 1fc09669-14b3-4d53-871c-6e6d41e87909
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elasto-Gel
• Version Model Number: DR8600
• Catalog Number: 2-025-002
• Company DUNS: 048078018
• Company Name: Southwest Technologies, Inc.
• Device Count: 5
• 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: true

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	00745713186008 [Unit of Use]
GS1	00745713486009 [Package]; Contains: 00745713586006; Package: Case [25 Units]; In Commercial Distribution
GS1	00745713586006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872165

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

On-Brand Devices [Elasto-Gel]

• 00745713486009: 6" x 8" Sterile Wound Dressing
• 00745713980002: 4" x 4" Sterile Wound Dressing
• 00745713982006: 2" x 3" Sterile Wound Dressing