FDA.report

MediChoice

Primary DI
50885632106963
Brand
MediChoice
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
ABN2100A
Device description
Bandage Adhesive Sheer 1 X 3 Inch Non-Adherent Pad Sterile Not Made With Natural Rubber Latex MediChoice
Published
2020-09-24
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
50885632106963PackageGS112In Commercial Distribution
30885632106969PrimaryGS10
10885632106965Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5088563210696350885632106963
3088563210696930885632106969
1088563210696510885632106965

GMDN Terms

TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00Store in a cool dry place, free from direct sunlight

Sterilization Methods

Method

Regulatory Flags

DUNS number
007941230
Device count
100
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

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