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Restorelle

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Restorelle FDA UDI
Generic Name
Pelvic organ prolapse surgical mesh, synthetic polymer FDA UDI
Device Name
Direct Fix™ Posterior Polypropylene Mesh FDA UDI
Model / Reference
501460 FDA UDI
Description
Direct Fix™ Posterior Polypropylene Mesh FDA UDI

Identifiers

Catalog Number
501460 FDA UDI
Primary DI / UDI-DI
05708932484084 FDA UDI
FDA Product Code
FTL 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

Dimensions & Sizes

Size
Length — 14 Centimeter FDA UDI
Width — 15 Centimeter FDA UDI

Category: Pelvic organ prolapse surgical mesh, synthetic polymer

Restorelle by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Coloplast A/S

Sources (1)

  • FDA UDI 6f0aff9f-b03d-4caf-89fc-faaf37e318c6 37 fields · synced Jun 1, 2026