ASAP OTC

GUDID 00851213004213

ASAP OTC Wound Dressing Gel, 4 oz

Abl Medical, LLC

Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial

• Primary Device ID: 00851213004213
• NIH Device Record Key: 18a16a42-ae06-4e45-8eac-139d02693799
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASAP OTC
• Version Model Number: 4 oz
• Company DUNS: 078644765
• Company Name: Abl Medical, LLC
• 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: true
• 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: (801)763-8000
• Email: info@ablmedical.com
• Phone: (801)763-8000
• Email: info@ablmedical.com
• Phone: (801)763-8000
• Email: info@ablmedical.com
• Phone: (801)763-8000
• Email: info@ablmedical.com

Device Dimensions

• Weight: 113 Gram
• Weight: 113 Gram
• Weight: 113 Gram
• Weight: 113 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851213004213 [Primary]
GS1	00851213004220 [Package]; Package: box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140483

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [ASAP OTC]

• 00851213004282: ASAP OTC Wound Dressing Gel, 5 grams
• 00851213004213: ASAP OTC Wound Dressing Gel, 4 oz
• 00851213004190: ASAP OTC Wound Dressing Gel, 1.5 oz