ALL-HEALTH Hydrocolloid Gel Cushions

Basic Information

• Brand Name: ALL-HEALTH Hydrocolloid Gel Cushions
• Primary DI: 00017276233957
• Version / Model: 017276233957
• Catalog Number: 017276233957
• Company Name: Aso LLC
• Labeler DUNS: 152793493
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-03-29
• Public Version: 2
• Public Version Date: 2022-08-04
• Public Version Status: Update
• Public Device Record Key: 2899136d-7e9c-41c3-9208-3f70de03bcff
• Distribution End Date: 2022-04-22

Device Description

Hydrocolloid Gel Blister Cushions, 42 mm x 68 mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61945	Corn/callus dressing, single-use	An adhesive dressing intended for protection of corns or calluses (hardened areas of skin on the feet or toes) or unopened blisters, and to maintain a moist environment to allow the lesion to heal. It consists of a pad of material (e.g., hydrocolloid) and may be impregnated with an acid (e.g., salicylic) which acts as a keratolytic agent to facilitate the removal of dead skin. It may be supplied with another dressing (e.g., ring) to provide additional protection/cushioning around the lesion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20017276233951	GS1	case	24	Not in Commercial Distribution	2022-04-22
Primary	00017276233957	GS1
Unit of Use	60017276233959	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]