FDA.report

CVS Health

Primary DI
20050428429987
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
235502
Device description
Plastic Bandages, all one size: 3/4 IN x 3 IN (19 mm x 76 mm)
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

Related Records

Product Codes

CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20050428429987PackageGS172In Commercial Distribution
00050428429983PrimaryGS10
60050428429985Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042842998720050428429987
00050428429983000504284299830504284299830050428429983
6005042842998560050428429985

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
062312574
Device count
60
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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10842942017541CVS4608662025-12-08

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