FDA.reportPublic FDA data

ALL-HEALTH Hydrocolloid Gel Bandages

Primary DI
20017276233838
Brand
ALL-HEALTH Hydrocolloid Gel Bandages
Company
Aso LLC
Model
017276233834
Catalog number
017276233834
Device description
Fast-healing Hydrocolloid Gel Bandages, assorted sizes (19 mm x 73 mm; 34 mm x 54 mm)
Published
2019-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
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
20017276233838PackageGS172In Commercial Distribution
00017276233834PrimaryGS10
60017276233836Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001727623383820017276233838
00017276233834000172762338340172762338340017276233834
6001727623383660017276233836

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, sterileA sterile wound covering, typically made of a hydrocolloid, hydrofibre, or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width19Millimeter
Width34Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8558234545regulatory@asocorp.com

Regulatory Flags#

DUNS number
152793493
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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