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Ultrapro

FDA UDI

Class II (US FDA UDI)

by Johnson & Johnson Medical, Inc.

Identity

Trade Name
ULTRAPRO FDA UDI
Generic Name
Extra-gynaecological surgical mesh, composite-polymer FDA UDI
Device Name
Ultrapro MONOCRYL?-PROLENE?-COMPOSITE Poliglecaprone 25/Polypropylene FDA UDI
Model / Reference
UML1 FDA UDI
Description
Ultrapro MONOCRYL?-PROLENE?-COMPOSITE Poliglecaprone 25/Polypropylene FDA UDI

Identifiers

Catalog Number
UML1 FDA UDI
Primary DI / UDI-DI
10705031085862 FDA UDI
510(k) Number
K033337 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

No

FDA UDI

Category: Extra-gynaecological surgical mesh, composite-polymer

Ultrapro by Johnson & Johnson Medical, 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

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Manufacturer

Manufacturer
Johnson & Johnson Medical, Inc.

Sources (1)

  • FDA UDI f86ad86f-1966-4244-a622-07792a7edc28 36 fields · synced Jun 8, 2026