FDA.report

ENDURE INDUSTRIES

Primary DI
00840118611541
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
EKR83A3
Catalog number
EKR83A3
Device description
Endure Skin Closures, Reinforced, 1/8" x 3"
Published
2023-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MKYSystem, Skin Closure

Product Code Classifications

CodeDeviceSpecialtyClass
MKYSystem, Skin ClosureGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840118611541PackageGS150In Commercial Distribution
00840118611534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118611541008401186115418401186115410840118611541
00840118611534008401186115348401186115340840118611534

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius49 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius49 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
6072994971support@endureind.com

Regulatory Flags

DUNS number
066087031
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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00840118600507EndureSP11A3-0520SP11A32020-11-19
00840118600538EndureSP21A3-0520SP21A32020-11-19
00840118600569EndureSP22A3-0520SP22A32020-11-19
00840118600590EndureSP31A3-0520SP31A32020-11-19
00840118600620EndureSP41A3-0520SP41A32020-11-19
00840118600651EndureSP42A3-0520SP42A32020-11-19
00840118600682EndureSP61A3-0520SP61A32020-11-19
00840118600712EndureSP62A3-0520SP62A32020-11-19
00840118600743EndureSP81A3-0520SP81A32020-11-19
00840118614566ENDURE INDUSTRIESIDABA8IDABA82024-10-04
00840118614597ENDURE INDUSTRIESIDAPA8IDAPA82024-10-04
00840118617840ENDURE INDUSTRIESUB1GA9UB1GA92024-04-17
00840118617871ENDURE INDUSTRIESUB2LA9UB2LA92024-04-17
00840118606660ENDURE INDUSTRIESCBP150A8CBP150A82024-04-10
00840118606684ENDURE INDUSTRIESCB70A8CB70A82024-04-10
00840118606707ENDURE INDUSTRIESCBTA8CBTA82024-04-10
00840118608077ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118615297ENDURE INDUSTRIESGS13GS132024-04-10
00840118609722ENDURE INDUSTRIESWSS44WSS442024-04-10
00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10

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06972864363024sknjxNingbo Chinmed Technology Co., Ltd.MKY2025-11-20
00844735006728DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
00844735006735DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
07540161750015AbCloInventorr MD IncMKY2023-12-04
00840118605182ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611442ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611466ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611480ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611503ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611527ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611565ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613651ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00860007834226HEMIGARD InterlockSUTUREGARD MEDICAL, INCMKY2022-10-03
10860007834223HEMIGARD InterlockSuturegard Medical IncMKY2022-10-03
10620974001703Dynamic Tissue Systems™Southmedic IncorporatedMKY2020-12-18
10620974001710Dynamic Tissue Systems™Southmedic IncorporatedMKY2020-12-18
10620974001727Dynamic Tissue Systems™Southmedic IncorporatedMKY2020-12-18
10620974001734Dynamic Tissue Systems™Southmedic IncorporatedMKY2020-12-18
10620974001741Dynamic Tissue Systems™Southmedic IncorporatedMKY2020-12-18
10620974001758Dynamic Tissue Systems™Southmedic IncorporatedMKY2020-12-18
10620974001765Dynamic Tissue Systems™Southmedic IncorporatedMKY2020-12-18
10620974001772Dynamic Tissue Systems™Southmedic IncorporatedMKY2020-12-18
10850010207152BandGrip® Micro-Anchor® ClosureBANDGRIP INC.MKY2020-07-27
10853114007277Zip PreLoc 2 Wound Closure DeviceZIPLINE MEDICAL, INC.MKY2020-05-21
00844735006216DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2020-04-09
00844735006223DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2020-04-09
10850010207121BandGrip® Micro-Anchor® ClosureBANDGRIP INC.MKY2020-03-24
00844735006124DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2019-04-12
00844735006131DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2019-04-12