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Gynecare Gynemesh

FDA UDI

Class II (US FDA UDI)

by Ethicon Inc.

Identity

Trade Name
GYNECARE GYNEMESH FDA UDI
Generic Name
Pelvic organ prolapse surgical mesh, synthetic polymer FDA UDI
Device Name
Nonabsorbable Prolene Soft Mesh FDA UDI
Model / Reference
GPSL FDA UDI
Description
Nonabsorbable Prolene Soft Mesh FDA UDI

Identifiers

Catalog Number
GPSL FDA UDI
Primary DI / UDI-DI
20705031037738 FDA UDI
510(k) Number
K013718 FDA UDI
FDA Product Code
OTO FDA UDI
GMDN Term
Pelvic organ prolapse surgical mesh, 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

Category: Pelvic organ prolapse surgical mesh, synthetic polymer

Gynecare Gynemesh by Ethicon Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pelvic organ prolapse surgical mesh, synthetic polymer.

Cleared under the same submission

K013718 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ethicon Inc.

Sources (1)

  • FDA UDI 1035cba1-f71b-4e05-bd97-ec8a34e0d0c0 37 fields · synced Jun 8, 2026