← Back to catalogue

Sepramesh

FDA UDI

Class II (US FDA UDI)

by Davol Inc.

Identity

Trade Name
SEPRAMESH FDA UDI
Generic Name
Extra-gynaecological surgical mesh, composite-polymer FDA UDI
Device Name
Sepramesh IP, 3" x 6" (7.6 cm x 15.2 cm), Rectangle FDA UDI
Model / Reference
5959360 FDA UDI
Description
Sepramesh IP, 3" x 6" (7.6 cm x 15.2 cm), Rectangle FDA UDI

Identifiers

Catalog Number
5959360 FDA UDI
Primary DI / UDI-DI
00801741031809 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, composite-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

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 7.6 Centimeter FDA UDI
Width — 15.2 Centimeter FDA UDI

Category: Extra-gynaecological surgical mesh, composite-polymer

Sepramesh by Davol Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extra-gynaecological surgical mesh, composite-polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Davol Inc.

Sources (1)

  • FDA UDI b1082394-5438-4386-ad4f-111d65a72e4f 37 fields · synced Jun 8, 2026