FDA.reportPublic FDA data

Premier Value

Primary DI
10840986021555
Brand
Premier Value
Company
PHARMACY VALUE ALLIANCE, LLC
Model
84098602155
Catalog number
84098602155
Device description
Sterile Wound Closure Strips- 1/4"x4"
Published
2022-06-21
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

Product Codes#

Code, Name table
CodeName
FPXStrip, Adhesive, Closure, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPXStrip, Adhesive, Closure, SkinGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K931005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K931005000DUKAL SKIN CLOSURE STRIPDukal Corp.1993-07-14FPX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840986021555PackageGS124In Commercial Distribution
00840986021558PrimaryGS10
00840986039997Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084098602155510840986021555
00840986021558008409860215588409860215580840986021558
00840986039997008409860399978409860399970840986039997

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
435-649-7251sjrule1@gmail.com

Regulatory Flags#

DUNS number
089138159
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840986019715Premier ValueDTT-12016-09-20
00840986027512Premier ValueKD-20502016-09-20
00840986021558Premier Value84098602155840986021552022-06-21
00840986036637Premier Value84098603663840986036632022-06-21
00840986016639Premier Value One Step Pregnancy Test2016-08-30
00840986016646Premier Value One Step Pregnancy Test2016-08-30
00840986021091Premier Value Early Result Pregnancy Test2016-08-30
00840986036996Premier ValueOne Step Pregnancy Test2020-09-21
00840986037009Premier ValueOne Step Pregnancy Test2020-09-21
00840986037108Premier ValueAdvanced One-Step Pregnancy Test2020-11-11
00840986034992Premier Value AutoletAT 0270CDC2023-02-03
00761059272281Premier Value AutoletAT 0270CDC2023-02-03
00840986016684Premier Value Unilet LancetsAT 0575CDC2023-01-06
00840986032837Premier Value Unilet LancetsAT 0585CDC2023-01-06
10840986037105Premier ValueAdvanced One-Step Pregnancy Test2020-11-11
10840986036634Premier Value84098603663840986036632022-06-21
00040986026847Premier Value TamponsBPVGR202016-09-20
00840986015854PREMIER VALUEF408-150CD2020-09-21
00840986016196Premier Value TamponsBPVAR402016-09-20
00840986016202Premier Value TamponsBPVAS402016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428344781CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFPX2026-05-25
30197344203530CURADMEDLINE INDUSTRIES, INC.FPX2026-05-15
00194346192038EquateWAL-MART STORES, INC.FPX2024-02-15
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
00017276239287Care ScienceAso LLCFPX2023-06-08
20017276239281Care ScienceAso LLCFPX2023-06-08
10665973008803DukalDukal LLCFPX2022-12-06
10665973008810DukalDukal LLCFPX2022-12-06
10665973008827DukalDukal LLCFPX2022-12-06
10665973008834DukalDukal LLCFPX2022-12-06
10665973008841DukalDukal LLCFPX2022-12-06
10665973008858DukalDukal LLCFPX2022-12-06
20665973008800DukalDukal LLCFPX2022-12-06
20665973008817DukalDukal LLCFPX2022-12-06
20665973008824DukalDukal LLCFPX2022-12-06
20665973008831DukalDukal LLCFPX2022-12-06
30665973008845DukalDukal LLCFPX2022-12-06
30665973008852DukalDukal LLCFPX2022-12-06
00840986021558Premier ValuePHARMACY VALUE ALLIANCE, LLCFPX2022-06-21
H65890043141Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043151Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043161Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043171Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890043181Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22
H65890075061Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22