FDA.reportPublic FDA data

TopClosure

Primary DI
07290108154009
Brand
TopClosure
Company
I.V.T. MEDICAL LTD
Model
1S-M Rescue Kit 8mm
Catalog number
1SM-R-SBL8-GI
Published
2017-08-13
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
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
17290108154006PackageGS110In Commercial Distribution
27290108154003PackageGS110In Commercial Distribution
07290108154009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010815400617290108154006
2729010815400327290108154003
07290108154009072901081540097290108154009

GMDN Terms#

Term, Definition table
TermDefinition
Skin-closing tension deviceA sterile device designed to apply continuous tension to an area of skin to stretch it to achieve a surplus of full thickness skin and subcutaneous tissue for the closure of a wound where the margins are too far apart for suturing, or prior to the surgical excision of a skin defect, or for the implantation of a prosthesis to provide additional skin for coverage; it may additionally be used for offloading sutures in closed wounds. It is typically available as automatic self-closing skin hooks, or a tension line inserted through skin hooks at the wound margins for constant or adjustable tension application. It may be used as an alternative to skin grafting. This is a single-use device.

Regulatory Flags#

DUNS number
514996339
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
07290111491009Vcare AlphaWound Dressing Kit 10x10SWDK10102017-08-13
07290111491108Vcare AlphaWound Dressing Kit 10x20SWDK10202017-08-13
07290111491207Vcare AlphaWound Dressing Kit 15x20SWDK15202017-08-13
07290111491306Vcare AlphaWound Dressing Kit 20x30SWDK 20302017-08-13
07290111491405Vcare AlphaWoind Dressing Kit 40x45SWDK40452017-08-13
07290111492006Vcare AlphaSponge Accessory Pack 10x102017-08-13
07290111492105Vcare AlphaSponge Accessory Pack 10x202017-08-13
07290111492204Vcare AlphaSponge Accessory Pack 15x202017-08-13
07290111492303Vcare AlphaSponge Accessory Pack 20x302017-08-13
07290111492402Vcare AlphaSponge Accessory Pack 40x452017-08-13
07290111493003Vcare AlphaROI-NPT Wound Dressing Kit 20x302017-08-13
07290111493102Vcare AlphaROI-NPT Wound Dressing Kit 40x452017-08-13
07290111494000Vcare AlphaIrrigation hose adapter accessory kitACC-IHF2017-08-13
07290111494109Vcare AlphaHose Adapter Accessory kitACC-HAPT2017-08-13
07290111494208Vcare AlphaDrape Accessory PackACC-5DRS2017-08-13
07290108154108TopClosure3S-M Rescue Kit 8mm3SM-R-SBL8-GI2018-11-13
07290111490002Vcare AlphaVcare α® DeviceVCA233e2017-08-13
07290111495007Vcare AlphaProximal TubeSPT1702017-08-13
07290111495106Vcare AlphaCollecting CanisterCC8002017-08-13
07290111495205Vcare AlphaCollecting Canister + Proximal Tube2017-08-13

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
00840118611497ENDURE 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