FDA.reportPublic FDA data

ALL-HEALTH Wound Care Products

Primary DI
20017276234453
Brand
ALL-HEALTH Wound Care Products
Company
Aso LLC
Model
017276234459
Device description
Rolled Gauze, all one size, 3 IN x 2.5 YDS (76 mm x 2.28 m)
Published
2020-02-28
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
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20017276234453PackageGS136In Commercial Distribution
00017276234459PrimaryGS10
60017276234451Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001727623445320017276234453
00017276234459000172762344590172762344590017276234459
6001727623445160017276234451

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze rollA sterile device in the form of a long strip of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
152793493
Device count
10
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
false
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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