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Titan

FDA UDI

Class III (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Titan FDA UDI
Generic Name
Inflatable penile prosthesis FDA UDI
Device Name
Infrapubic Bioflex® Cylinder Set with Pump - Narrow FDA UDI
Model / Reference
90-9816INC FDA UDI
Description
Infrapubic Bioflex® Cylinder Set with Pump - Narrow FDA UDI

Identifiers

Catalog Number
90-9816INC FDA UDI
Primary DI / UDI-DI
05708932322348 FDA UDI
PMA Number
P000006 FDA UDI
FDA Product Code
FHW FDA UDI
GMDN Term
Inflatable penile prosthesis FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
876.3350 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
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 16 Centimeter FDA UDI

Category: Inflatable penile prosthesis

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

Similar devices

Also classified as Inflatable penile prosthesis.

Cleared under the same submission

P000006 also covers:

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 a06a0ddb-5fff-45cb-9a08-23fac6979cae 38 fields · synced May 30, 2026