FDA.report

CVS Health

Primary DI
00050428340417
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
875951
Device description
Flexible Fabric Antibacterial Bandages, assorted sizes, 5/8 IN x 2 1/4 IN (15 mm x 57 mm), 3/4 IN x 3 IN (19 mm x 76 mm), 1 IN x 3 IN (25 mm x 76 mm)
Published
2021-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00050428340417PrimaryGS10
10050428340414Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428340417000504283404170504283404170050428340417
1005042834041410050428340414

GMDN Terms

TermDefinition
Skin-cover adhesive strip, antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062312574
Device count
30
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company

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00050428044940CVS6158032026-05-26
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00050428344781CVS0504283447812026-05-25
20050428020849CVS HealthCVS376561V22026-03-23
00050428339770CVS Health16CVS015073291982026-03-20
10050428001025CVS 797412BM22-12026-02-27
00050428005408CVS 841855WF032026-02-13
00050428005415CVS 845712WF132026-02-13
00050428005422CVS 837160WF232026-02-13
40050428029495CVS6354782026-02-13
00050428057186CVSHealth1017042026-02-04
00050428073421CVSHealth1044172026-02-04
00050428080863CVSHealth1059932026-02-04
00050428005583CVS 689466LB152026-01-28
10050428005603CVS 689509LB262026-01-26
10050428005610CVS 689573LB462026-01-23
10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
00050428005804CVS 275172BF7222025-12-10

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10885632468506HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468513HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468520HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509032HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
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