FDA.report

CVS Health

Primary DI
20050428288461
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
955729
Device description
Wound Closures: 1/4 IN x 4 IN (6.35 mm x 101 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
FPXStrip, Adhesive, Closure, Skin

Product Code Classifications

CodeDeviceSpecialtyClass
FPXStrip, Adhesive, Closure, SkinGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20050428288461PackageGS136In Commercial Distribution
00050428288467PrimaryGS10
60050428288469Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042828846120050428288461
00050428288467000504282884670504282884670050428288467
6005042828846960050428288469

GMDN Terms

TermDefinition
Skin-closure adhesive stripA small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. 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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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10050428005603CVS 689509LB262026-01-26
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10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
00050428005804CVS 275172BF7222025-12-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00050428344781CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFPX2026-05-25
20194346192032EquateWAL-MART STORES, INC.FPX2024-02-15
10849233004822Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
20849233004874Busse Hospital DisosablesROBERT BUSSE & CO., INC.FPX2023-06-16
10849233004884Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
10849233004891Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
20849233005000Busse Hospital DisposablesROBERT BUSSE & CO., INC.FPX2023-06-16
20017276239281Care ScienceAso LLCFPX2023-06-08
20665973008800DukalDukal LLCFPX2022-12-06
20665973008817DukalDukal LLCFPX2022-12-06
20665973008824DukalDukal LLCFPX2022-12-06
20665973008831DukalDukal LLCFPX2022-12-06
30665973008845DukalDukal LLCFPX2022-12-06
30665973008852DukalDukal LLCFPX2022-12-06
10840986021555Premier ValuePHARMACY VALUE ALLIANCE, LLCFPX2022-06-21
H65890043142Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043152Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043162Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043172Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043182Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890075062Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
00840113201327Aspen® Skin ClosureASPEN SURGICAL PRODUCTS, INC.FPX2021-02-25
00840113201358Aspen® Skin ClosureASPEN SURGICAL PRODUCTS, INC.FPX2021-02-25
00840113201372Aspen® Skin ClosureASPEN SURGICAL PRODUCTS, INC.FPX2021-02-25
00840113201389Aspen® Skin ClosureASPEN SURGICAL PRODUCTS, INC.FPX2021-02-25
00840113225248Sterion® Skin ClosureASPEN SURGICAL PRODUCTS, INC.FPX2021-02-25
00840113225255Sterion® Skin ClosureASPEN SURGICAL PRODUCTS, INC.FPX2021-02-25
00840113225293Sterion® Skin ClosureASPEN SURGICAL PRODUCTS, INC.FPX2021-02-25
00840113225316Sterion® Skin ClosureASPEN SURGICAL PRODUCTS, INC.FPX2021-02-25
00840113225347Sterion® Skin ClosureASPEN SURGICAL PRODUCTS, INC.FPX2021-02-25