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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M689SDRTBBOTC020SDR Tactical Battle Belt IFAK-OTCSafeguard US Operating, LLCOHO2026-08-25
00842209139620NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139637NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139644NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139651NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139668NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139675NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139705NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139750NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139811NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139828NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139835NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00842209139842NARNORTH AMERICAN RESCUE, LLCOHO2026-08-19
00199972000443CuraplexBOUND TREE MEDICAL, LLCOHO2026-08-15
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00850056748735Pacific BiomedicalINTEGRATED MEDCRAFT LLCOHO2026-07-30
M6898723101030Bleeding Control KitSafeguard US Operating, LLCOHO2026-07-30
M6898810501060Patrol Officer IFAK BasicSafeguard US Operating, LLCOHO2026-07-27