Acutarex

GUDID 05060996770023

PDR Ointment Impregnated Gauze Non-Adherent Dressing: 4x4 Gauze

Alliance Healing Technologies, LLC

Wound-nonadherent dressing, permeable, non-antimicrobial

• Primary Device ID: 05060996770023
• NIH Device Record Key: 196808c6-156e-48d6-909e-38b0d56c460f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acutarex
• Version Model Number: 4x4
• Company DUNS: 124808420
• Company Name: Alliance Healing Technologies, 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: 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: 603-731-1630
• Email: complaints@alliancehealingtech.com
• Phone: 603-731-1630
• Email: complaints@alliancehealingtech.com
• Phone: 603-731-1630
• Email: complaints@alliancehealingtech.com

Device Dimensions

• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch
• Length: 4 Inch
• Width: 4 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060996770023 [Primary]
GS1	05060996770030 [Package]; Package: Box [240 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041059

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: 2026-03-23
• Device Publish Date: 2026-03-13