FDA.report

My Martin's

Primary DI
10041520091014
Brand
My Martin's
Company
Aso LLC
Model
041520091017
Device description
Vaccine Adhesive Bandages, all one size, 3/4 IN x 3 IN
Published
2019-06-28
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

Related Records

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10041520091014PackageGS172In Commercial Distribution
00041520091017PrimaryGS10
60041520091019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004152009101410041520091014
00041520091017000415200910170415200910170041520091017
6004152009101960041520091019

GMDN Terms

TermDefinition
Skin-cover adhesive stripA small, narrow, flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive and possibly with an absorbent pad, typically intended to cover a superficial wound or fix a dressing to skin. It may be hypoallergenic and/or waterproof, however it does not include antimicrobial agents/properties. Commonly referred to as a sticking plaster, it is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
152793493
Device count
40
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

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