FDA.reportPublic FDA data

Clozex Wound Closure

Primary DI
00850019787061
Brand
Clozex Wound Closure
Company
Clozex Medical, INC
Model
CL1050L
Device description
Clozex Closures, 50mm (2in.), Box of 10 Closure Devices
Published
2025-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MZRTopical Approximation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MZRTopical Approximation SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019787061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019787061008500197870618500197870610850019787061

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.

Regulatory Flags#

DUNS number
138266072
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019787009Clozex Wound ClosureCL10100L2025-10-28
00850019787016Clozex Wound ClosureCL1020S2025-10-28
00850019787023Clozex Wound ClosureCL1025S2025-10-28
00850019787030Clozex Wound ClosureCL1015S2025-10-28
00850019787047Clozex Wound ClosureCL1080L2025-10-28
00850019787054Clozex Wound ClosureCL1060L2025-10-28
00850019787078Clozex Wound ClosureCL1040L2025-10-28
00850019787085Clozex Wound ClosureCL1040S2025-10-28
00850019787092Clozex Wound ClosureCL1030S2025-10-28
00850019787108Clozex Wound ClosureLK01502025-10-28
00850019787115Clozex Wound ClosureLA03602025-10-28
00850019787313Clozex Wound ClosureLA31102025-10-28
00860002036502Clozex Wound ClosureLK01402025-10-28
00860002036519Clozex Wound ClosureLK02652025-10-28
00860002036526Clozex Wound ClosureLC02252025-10-28
00860002036540Clozex Wound ClosureLC02402025-10-28
00860002036595Clozex Wound ClosureLA03902025-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850019787009Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787016Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787023Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787030Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787047Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787054Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787078Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787085Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787092Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787115Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787313Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00860002036526Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00860002036540Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00860002036595Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00860010953938LipAlignCleftalign Inc.MZR2024-08-20
00860010953945LipAlignCleftalign Inc.MZR2024-08-20
00860010953952LipAlignCleftalign Inc.MZR2024-08-20
00860010953907NoseAlignCleftalign Inc.MZR2023-11-24
00860010953914NoseAlignCleftalign Inc.MZR2023-11-24
00860010953921NoseAlignCleftalign Inc.MZR2023-11-24
05000223448974LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449063LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449124LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449155LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449216LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449643LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449674LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223448981LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449070LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19
05000223449131LEUKOSTRIP™SMITH & NEPHEW MEDICAL LIMITEDMZR2021-11-19