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Gynecare Tvt

FDA UDI

Class II (US FDA UDI)

by Ethicon Sàrl

Identity

Trade Name
GYNECARE TVT FDA UDI
Generic Name
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Device Name
Tension-free support, Blue Polypropylene Mesh Tape FDA UDI
Model / Reference
810041BL FDA UDI
Description
Tension-free support, Blue Polypropylene Mesh Tape FDA UDI

Identifiers

Catalog Number
810041BL FDA UDI
Primary DI / UDI-DI
10705031062290 FDA UDI
FDA Product Code
OTN FDA UDI
GMDN Term
Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Female stress urinary incontinence surgical mesh-sling, synthetic polymer

Gynecare Tvt by Ethicon Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Female stress urinary incontinence surgical mesh-sling, synthetic polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Sàrl

Sources (1)

  • FDA UDI 98b19cdc-d588-40ae-b3b0-3cedc0b37d14 35 fields · synced May 30, 2026