FDA.reportPublic FDA data

First Aid Only

Primary DI
00092265906579
Brand
First Aid Only
Company
Acme United Corporation
Model
90657
Catalog number
90657
Device description
" Trauma Pad, 5"" x 9"" - 4 pads"
Published
2021-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00092265906579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00092265906579000922659065790922659065790092265906579

GMDN Terms#

Term, Definition table
TermDefinition
Non-woven gauze pad, sterileA non-medicated sterile device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-835-2263xxx@xx.xx

Regulatory Flags#

DUNS number
001180207
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00092265917841First Aid Only917842026-04-23
00738743007139First Aid Only3606493606492022-01-10
00092265001472First Aid OnlyAN147AN1472021-08-10
00092265313179First Aid OnlyFAE-3131FAE-31312021-08-10
00073577900998First Aid Only90099-00290099-0022020-10-02
00092265100977First Aid Only10097100972020-10-02
00738743080309First Aid Only803080302020-12-11
00092265716086First Aid Only7116087116082020-10-06
00092265960021First Aid Only96002960022025-09-30
00092265508391First Aid OnlyM5083M50832022-01-21
00092265508490First Aid OnlyM5084M50842022-01-21
00092265508599First Aid OnlyM5085M50852022-01-21
00092265508698First Aid OnlyM5086M50862022-01-21
00092265508797First Aid OnlyM5087M50872022-01-21
00092265508896First Aid OnlyM5088M50882022-01-21
00738743210119First Aid Only21-01121-0112022-12-15
00092265022040First Aid OnlyB204B2042021-07-15
00738743961424Elite First Aid96142961422025-06-12
00738743961431Elite First Aid96143961432025-06-12
00092265002066First Aid OnlyAN206AN2062021-08-11

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