FDA.reportPublic FDA data

Dukal

Primary DI
10665973008834
Brand
Dukal
Company
Dukal LLC
Model
5150
Catalog number
5150
Device description
"DK 1/8""x3"" Wound Close Strip ST"
Published
2022-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
20665973008831PackageGS150In Commercial Distribution
30665973008838PackageGS14In Commercial Distribution
10665973008834PrimaryGS10
00665973008837Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2066597300883120665973008831
3066597300883830665973008838
1066597300883410665973008834
00665973008837006659730088376659730088370665973008837

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.

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
5
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973029488UnipackUGC-6600-LUGC-6600-L2022-12-06
10665973029495UnipackUGC-6600-MUGC-6600-M2022-12-06
10665973029501UnipackUGC-6600-SUGC-6600-S2022-12-06
10665973029518UnipackUGC-6600-XLUGC-6600-XL2022-12-06
10665973029525UnipackUGC-6600-XXLUGC-6600-XXL2022-12-06
10665973029532UnipackUGC-6601-LUGC-6601-L2022-12-06
10665973029549UnipackUGC-6601-MUGC-6601-M2022-12-06
10665973029556UnipackUGC-6601-SUGC-6601-S2022-12-06
10665973029563UnipackUGC-6601-XLUGC-6601-XL2022-12-06
10665973029570UnipackUGC-6601-XXLUGC-6601-XXL2022-12-06
10665973029587UnipackUGC-6602-LUGC-6602-L2022-12-06
10665973029594UnipackUGC-6602-MUGC-6602-M2022-12-06
10665973029600UnipackUGC-6602-SUGC-6602-S2022-12-06
10665973029617UnipackUGC-6602-XLUGC-6602-XL2022-12-06
10665973029624UnipackUGC-6602-XXLUGC-6602-XXL2022-12-06
10665973029631UnipackUGC-6603-LUGC-6603-L2022-12-06
10665973029648UnipackUGC-6603-MUGC-6603-M2022-12-06
10665973029655UnipackUGC-6603-SUGC-6603-S2022-12-06
10665973029662UnipackUGC-6603-XLUGC-6603-XL2022-12-06
10665973029679UnipackUGC-6603-XXLUGC-6603-XXL2022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344203547CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203554CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203561CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203578CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
30197344203585CURADMEDLINE INDUSTRIES, INC.FPX2026-06-09
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
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
10840986021555Premier ValuePHARMACY VALUE ALLIANCE, LLCFPX2022-06-21
H65890043141Henry ScheinHENRY SCHEIN, INC.FPX2021-07-22