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Genesis

FDA UDI

Class II (US FDA UDI)

by Coloplast A/S

Identity

Trade Name
Genesis FDA UDI
Generic Name
Rigid penile prosthesis FDA UDI
Device Name
Malleable Penile Prosthesis FDA UDI
Model / Reference
91-9511SC FDA UDI
Description
Malleable Penile Prosthesis FDA UDI

Identifiers

Catalog Number
91-9511SC FDA UDI
Primary DI / UDI-DI
05708932324748 FDA UDI
510(k) Number
K040959 FDA UDI
FDA Product Code
FAE FDA UDI
GMDN Term
Rigid penile prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.3630 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
Outer Diameter — 11 Millimeter FDA UDI

Category: Rigid penile prosthesis

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

Similar devices

Also classified as Rigid penile prosthesis.

Cleared under the same submission

K040959 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 2aab0596-b065-4aa9-bf19-64f89d443ced 38 fields · synced May 30, 2026