FDA.reportPublic FDA data

Clozex Wound Closure

Primary DI
00850019787030
Brand
Clozex Wound Closure
Company
Clozex Medical, INC
Model
CL1015S
Device description
Clozex Closures, 15mm (5/8in.), 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
00850019787030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019787030008500197870308500197870300850019787030

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
No natural rubber latex
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
00850019787047Clozex Wound ClosureCL1080L2025-10-28
00850019787054Clozex Wound ClosureCL1060L2025-10-28
00850019787061Clozex Wound ClosureCL1050L2025-10-28
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
00850019787047Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787054Clozex Wound ClosureClozex Medical, INCMZR2025-10-28
00850019787061Clozex 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