ALL-HEALTH Hydrocolloid Gel Cushions

Basic Information

• Brand Name: ALL-HEALTH Hydrocolloid Gel Cushions
• Primary DI: 00017276233933
• Version / Model: 017276233933
• Catalog Number: 017276233933
• Company Name: Aso LLC
• Labeler DUNS: 152793493
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2019-03-29
• Public Version: 1
• Public Version Date: 2019-04-08
• Public Version Status: New
• Public Device Record Key: cb79a8c6-6397-4e5a-bf9e-d9d06d4cde4e

Device Description

Hydrocolloid Gel Blister Cushions, assorted sizes (17 mm x 59 mm; 34 mm x 54 mm; 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
62873	Exudate-absorbent dressing, hydrophilic-gel, non-sterile	A non-sterile adhesive covering intended to assist treatment and protection of fluid-filled superficial lesions (e.g., cold sores, mild acne spots/pimples, opened blisters) and/or minor abrasions by producing a water-absorbent gel upon contact with exudate and maintaining a moist environment; it does not contain an antimicrobial agent. It may be available in various forms (e.g., flat sheet/film, pad) and is typically made of hydrocolloid. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20017276233937	GS1	case	72	In Commercial Distribution
Primary	00017276233933	GS1
Unit of Use	60017276233935	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	42	Millimeter
Width	34	Millimeter
Width	17	Millimeter