FDA.reportPublic FDA data

Clozex Wound Closure

Primary DI
00850019787108
Brand
Clozex Wound Closure
Company
Clozex Medical, INC
Model
LK0150
Device description
Laceration Kit 1 Closure: 50mm and Accessories
Published
2025-10-28
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

Product Codes#

Code, Name table
CodeName
OHOFirst Aid Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHOFirst Aid Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019787108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019787108008500197871088500197871080850019787108

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
Kit
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
00850019787061Clozex Wound ClosureCL1050L2025-10-28
00850019787078Clozex Wound ClosureCL1040L2025-10-28
00850019787085Clozex Wound ClosureCL1040S2025-10-28
00850019787092Clozex Wound ClosureCL1030S2025-10-28
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

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Primary DI, Brand, Company table
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00842209139286NARNORTH AMERICAN RESCUE, LLCOHO2026-07-06
00842209139293NARNORTH AMERICAN RESCUE, LLCOHO2026-07-06
00842209139231NARNORTH AMERICAN RESCUE, LLCOHO2026-06-22
00842209139248NARNORTH AMERICAN RESCUE, LLCOHO2026-06-22
M689SHSTARTPAXSM030SCHOOL TRAUMA ADVANCED RESPONSE KITSafeguard US Operating, LLCOHO2026-06-22
M689SHSTARTSM030School Trauma Active Response KitSafeguard US Operating, LLCOHO2026-06-22
00049696295260THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295277THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295284THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295291THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295307THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
00049696295314THERA PlusFOURSTAR GROUP INC.OHO2026-06-09
06953395551029JINGDIJINHUA JINGDI MEDICAL SUPPLIES CO.,LTDOHO2026-06-05
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06975675788109Rhino RescueEMSRUN GROUPOHO2026-06-01
M6898143003020Maritime Boat Box - AdvancedSafeguard US Operating, LLCOHO2026-05-28
00842209138760NARNORTH AMERICAN RESCUE, LLCOHO2026-05-27