← Back to catalogue

Prolene

FDA UDI

Class II (US FDA UDI)

by Ethicon Inc.

Identity

Trade Name
PROLENE FDA UDI
Generic Name
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Device Name
Soft Polypropylene Mesh, Nonabsorbable Synthetic Surgical Mesh FDA UDI
Model / Reference
SPMS FDA UDI
Description
Soft Polypropylene Mesh, Nonabsorbable Synthetic Surgical Mesh FDA UDI

Identifiers

Catalog Number
SPMS FDA UDI
Primary DI / UDI-DI
10705031050495 FDA UDI
FDA Product Code
FTL FDA UDI
GMDN Term
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable 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: Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

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

Similar devices

Also classified as Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.

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
Ethicon Inc.

Sources (1)

  • FDA UDI 2e6f81b0-0866-4b24-84d6-c5bda1942d49 35 fields · synced May 30, 2026