FDA.reportPublic FDA data

LEUKOSTRIP 6.4X76MM CTN 50

Primary DI
05000223449032
Brand
LEUKOSTRIP 6.4X76MM CTN 50
Company
SMITH & NEPHEW MEDICAL LIMITED
Model
66002878
Catalog number
66002878
Device description
Wound closure strips
Published
2020-04-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05000223449049PackageGS150In Commercial Distribution
05000223449056PackageGS14In Commercial Distribution
05000223449032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05000223449049050002234490495000223449049
05000223449056050002234490565000223449056
05000223449032050002234490325000223449032

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.

Regulatory Flags#

DUNS number
216344051
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
05000223482589CICA CARE66801491668014912026-04-30
05000223502157CICA CARE66803184668031842026-04-30
05000223502270ACTICOAT Flex66027686660276862026-04-29
05000223502300ACTICOAT Flex66027687660276872026-04-29
05000223502331ACTICOAT Flex66027688660276882026-04-29
05000223502249ACTICOAT Flex66027685660276852026-04-28
05000223502218ACTICOAT FLEX66027684660276842026-03-26
05000223503727ACTICOAT Flex66027683660276832026-03-26
05000223503956LEAF66807739668077392026-03-03
05000223503994LEAF66807745668077452026-03-01
00040565117737COVRSITE5971430059714300 / 597144002026-01-19
00040565117690COVRSITE5971400059714000 / 597141002026-01-19
00040565120249COVRSITE59715000597150002026-01-19
00040565120263COVRSITE59715100597151002026-01-19
00040565117706COVRSITE5971400059714000 / 597141002026-01-19
00040565117744COVRSITE5971430059714300 / 597144002026-01-19
00040565120256COVRSITE59715000597150002026-01-19
00040565120270COVRSITE59715100597151002026-01-19
05000223494643PICO66022022660220222018-08-23
05000223494650PICO66022023660220232018-08-23

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
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