FDA.reportPublic FDA data

GYNECARE TVT ABBREVO

Primary DI
10705031062368
Brand
GYNECARE TVT ABBREVO
Company
Ethicon Sàrl
Model
TVTOML
Catalog number
TVTOML
Device description
Continence System
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OTNmesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705031062368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503106236810705031062368

GMDN Terms#

Term, Definition table
TermDefinition
Stress urinary incontinence surgical mesh, femaleA sterile woven/knitted or porous material made of non-bioabsorbable synthetic polymer (e.g., polypropylene) intended to be permanently implanted (via transobturator, transvaginal, retropubic or suprapubic approach) to support the urethra for the treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). It typically includes an integral adjustment suture which may contain bioabsorbable polymer materials. It may be referred to as a sling, tape, or subfascial hammock, and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., needles, sheaths) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damaged
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
480920383
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031062306GYNECARE TVT810081L810081L2015-09-23
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
10705031003026SURGICEL195219522014-09-20
10705031003033SURGICEL195319532014-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00890594000124Desara Blue TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000131Desara TVez 2.7Caldera Medical, Inc.OTN2022-08-03
00890594000155Desara TVez 3.0Caldera Medical, Inc.OTN2022-08-03
00890594000193Desara Blue TVez 2.7Caldera Medical, Inc.OTN2022-08-03
00890594000087Desara Blue TVez 3.0Caldera Medical, Inc.OTN2021-11-15
00890594000094Desara Blue TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000100Desara TVez 2.7Caldera Medical, Inc.OTN2021-11-15
00890594000117Desara TVez 3.0Caldera Medical, Inc.OTN2021-11-15
00191506007652Advantage Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00191506007669Advantage Fit Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00191506007676Lynx Ultra SystemBOSTON SCIENTIFIC CORPORATIONOTN2021-10-06
00860003619810Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
00860003619803Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
20860003619814Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
00860003619827Athena Surgical RMUS SystemAthena Surgical LLCOTN2021-07-30
08437007606027Remeex System (for Female Urinary Incontinence)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606065KIM (Knotless Incontinence Mesh)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606072Remeex System -Readjustment kit DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606263Remeex System - Thread PasserDESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606683KIM (Knotless Incontinence Mesh)DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
08437007606836Remeex System - Passer Handle DESARROLLO E INVESTIGACION MEDICA ARAGONESA SLOTN2020-10-19
00890594000858Desara Blue TVCaldera Medical, Inc.OTN2019-09-30
00890594000896DesaraCaldera Medical, Inc.OTN2019-09-30
00890594000902Desara TV Caldera Medical, Inc.OTN2019-09-30
00890594000841Desara Blue TVCALDERA MEDICAL, INC.OTN2019-09-30
00890594000889DesaraCALDERA MEDICAL, INC.OTN2019-09-30
00890594000919Desara TV CALDERA MEDICAL, INC.OTN2019-09-30
00860368002401ArcTV™ Transvaginal Sling SystemUROCURE LLCOTN2019-08-13
08714729961918Advantage™ Blue SystemBOSTON SCIENTIFIC CORPORATIONOTN2018-01-22
08714729961925Advantage Fit™ Blue SystemBOSTON SCIENTIFIC CORPORATIONOTN2018-01-22