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Bulkamid

FDA UDI

Class III (US FDA UDI)

by Contura International A/S

Identity

Trade Name
Bulkamid FDA UDI
Generic Name
Urological surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Bulkamid Urethral Bulking System FDA UDI
Model / Reference
50050 FDA UDI
Description
Bulkamid Urethral Bulking System FDA UDI

Identifiers

Primary DI / UDI-DI
05704101500500 FDA UDI
FDA Product Code
LNM FDA UDI
GMDN Term
Urological surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Urological surgical procedure kit, non-medicated, single-use

Bulkamid by Contura International A/S — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urological surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Contura International A/S

Sources (1)

  • FDA UDI 41bd2db8-69d5-4d6d-831b-636c69a8e7df 34 fields · synced May 30, 2026