FDA.reportPublic FDA data

ALL-HEALTH Hydrocolloid Gel Cushions

Primary DI
00017276233957
Brand
ALL-HEALTH Hydrocolloid Gel Cushions
Company
Aso LLC
Model
017276233957
Catalog number
017276233957
Device description
Hydrocolloid Gel Blister Cushions, 42 mm x 68 mm
Published
2019-03-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20017276233951PackageGS124Not in Commercial Distribution
00017276233957PrimaryGS10
60017276233959Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001727623395120017276233951
00017276233957000172762339570172762339570017276233957
6001727623395960017276233959

GMDN Terms#

Term, Definition table
TermDefinition
Corn/callus dressing, single-useAn 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.

Contacts#

Phone, Email table
PhoneEmail
1-855-823-4545regulatory@asocorp.com

Regulatory Flags#

DUNS number
152793493
Device count
5
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017276241709Rapid Seal0172762417092026-05-27
00017276230734Emoji0172762307342020-04-30
00017276238709CARE SCIENCE0172762387092022-01-24
00017276240818Bluey0172762408182025-08-13
00017276236378Wonder Woman Antibacterial Bandages0172762363782020-04-29
00017276236538LOL Surprise Antibacterial Bandages0172762365382020-02-28
00017276238617Clear Passage Nasal Strips0172762386172021-11-15
00017276221169Garfield017276221169GAR52932020-09-20
00017276230598CarePak0172762305982020-07-29
00017276231854Careband- EMOJI1842562020-09-27
00017276232820Antibacterial PJ Masks Bandages0172762328202020-02-28
00017276233667ALL-HEALTH Adhesive Bandages0172762336670172762336672019-03-29
00017276233841ALL-HEALTH Hydrocolloid Gel Bandages0172762338410172762338412019-03-29
00017276233865ALL-HEALTH Hydrocolloid Gel Bandages0172762338650172762338652019-03-29
00017276233889ALL-HEALTH Hydrocolloid Gel Bandages0172762338890172762338892019-03-29
00017276233896ALL-HEALTH Hydrocolloid Gel Bandages0172762338960172762338962019-03-29
00017276233902ALL-HEALTH Hydrocolloid Gel Cushions0172762339020172762339022019-03-29
00017276233926ALL-HEALTH Hydrocolloid Gel Cushions0172762339260172762339262019-03-29
00017276233933ALL-HEALTH Hydrocolloid Gel Cushions0172762339330172762339332019-03-29
00017276234060ALL-HEALTH Adhesive Bandages0172762340600172762340602019-03-29

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