FDA.reportPublic FDA data

GYNECARE TVT

Primary DI
10705031062238
Brand
GYNECARE TVT
Company
Ethicon Sàrl
Model
810051
Catalog number
810051
Device description
Reusable Introducer
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705031062238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503106223810705031062238

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic needle handleA hand-held manual surgical device designed to be attached to the proximal end of a suprapubic needle to functions as a handle to allow manipulation of the needle, typically during implantation a female stress urinary incontinence (SUI) surgical mesh/sling. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
480920383
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031002975SURGICEL NU-KNIT194319432014-09-20
10705031062306GYNECARE TVT810081L810081L2015-09-23
10705031062368GYNECARE TVT ABBREVOTVTOMLTVTOML2015-09-23
10705031062375GYNECARE TVT EXACTTVTRLTVTRL2015-09-23
10705031000346GYNECARE TVT8100818100812015-09-23
10705031002999SURGICEL NU-KNIT194619462014-09-20
10705031003118SURGICEL FIBRILLAR196119612014-09-20
10705031003125SURGICEL FIBRILLAR196219622014-09-20
10705031003132SURGICEL FIBRILLAR196319632014-09-20
10705031005396GYNECARE INTERCEED435043502014-09-20
10705031468092SURGICEL NU-KNIT1943S1943S2023-05-15
10705031468108SURGICEL1951S1951S2023-05-15
10705031468115SURGICEL1952S1952S2023-05-15
10705031468122SURGICEL1953S1953S2023-05-15
10705031468139SURGICEL1955S1955S2023-05-15
10705031468085SURGICEL NU-KNIT1940S1940S2023-07-28
10705031002951SURGICEL NU-KNIT194019402016-10-19
30705031468089SURGICEL NU-KNIT1940S1940S2023-07-28
10705031002968SURGICEL NU-KNIT194119412016-10-19
10705031003019SURGICEL195119512014-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091759ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091810ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091841ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091858ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091889ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091483ELMED INCORPORATEDELMED INCORPORATEDKOA2026-06-09
00850081334040Zenflow Spring® Implant Retrieval DeviceZENFLOW, INC.KOA2026-05-22
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
24026704941616PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
00198506089640ELMED INCORPORATEDELMED INCORPORATEDKOA2026-03-17
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00198506088537ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
00198506088599ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
50198956293241CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00190776417307MillenniumAvalign Technologies, Inc.KOA2026-02-20
00198506088155ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-22
00198506087363ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00198506087424ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412999MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412722MillenniumAvalign Technologies, Inc.KOA2025-10-06
00842180149724ELMED INCORPORATEDELMED INCORPORATEDKOA2025-09-30
00190776410360MillenniumAvalign Technologies, Inc.KOA2025-09-11
00190776409562MillenniumAvalign Technologies, Inc.KOA2025-09-03
05996617000050UroDapter®/MID-IIPHARMICO MEDICAL Korlátolt Felelősségű TársaságKOA2025-08-25