FDA.reportPublic FDA data

ENDURE INDUSTRIES

Primary DI
00840118611497
Brand
ENDURE INDUSTRIES
Company
ENDURE INDUSTRIES
Model
EKR43A3
Catalog number
EKR43A3
Device description
"Endure Skin Closures, Reinforced, 1/4"" x 3"""
Published
2023-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKYSystem, Skin Closure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKYSystem, Skin ClosureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840118611503PackageGS150In Commercial Distribution
00840118611497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118611503008401186115038401186115030840118611503
00840118611497008401186114978401186114970840118611497

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius49 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius49 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
6072994971support@endureind.com

Regulatory Flags#

DUNS number
066087031
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840118613958ENDURE INDUSTRIESNDAM211NDAM2112026-05-01
08697645018129ENDURE INDUSTRIESAMT4MAMT4M2026-04-17
08697645018136ENDURE INDUSTRIESAMT5M2026-04-17
08697645018143ENDURE INDUSTRIESAMT6MAMT6M2026-04-17
08697645018150ENDURE INDUSTRIESBGE7MBGE7M2026-04-17
08697645018167ENDURE INDUSTRIESBGE9MBGE9M2026-04-17
08697645018174ENDURE INDUSTRIESBGA7MBGA7M2026-04-17
08697645018181ENDURE INDUSTRIESBGA9M BGA9M 2026-04-17
08697645018198ENDURE INDUSTRIESBB1MBB1M2026-04-17
00840118603676EndureSLL1A3-0520SLL1A32021-04-06
00840118603706EndureSLL2A3-0520SLL2A32020-08-31
00840118603737EndureSLL3A3-0520SLL3A32021-07-25
00840118603768EndureSLL5A3-0520SLL5A32020-08-31
00840118603799EndureSLL10A3-0520SLL10A32020-08-31
00840118603829EndureSLL20A3-0520SLL20A32020-08-31
00840118603850EndureSLL50A3-0520SLL50A32020-08-31
00840118603881EndureSLS1A3-0520SLS1A32020-09-15
00840118603911EndureSLS2A3-0520SLS2A32020-09-15
00840118603942EndureSLS3A3-0520SLS3A32020-09-15
00840118603973EndureSLS5A3-0520SLS5A32020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007834257SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
10860007834254SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
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
00840118605175ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611435ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611459ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611473ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611510ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611534ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611558ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613644ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
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
00840118611541ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611565ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613651ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
08800125000020DIALFIX 11DFIXMKY2023-01-28
08800125000037DIALFIX 15DFIXMKY2023-01-28
08800125000044DIALFIX 18DFIXMKY2023-01-28
08800125000051DIALFIX 21DFIXMKY2023-01-28
08800125000068DIALFIX 24DFIXMKY2023-01-28
08800125000075DIALFIX PLUS 3DFIXMKY2023-01-28
08800125000082DIALFIX PLUS 5DFIXMKY2023-01-28