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Spectra

FDA UDI

Class II (US FDA UDI)

by American Medical Systems, Inc.

Identity

Trade Name
Spectra FDA UDI
Generic Name
Rigid penile prosthesis FDA UDI
Device Name
Concealable Penile Prosthesis, 2 Cylinders FDA UDI
Model / Reference
720056-02 FDA UDI
Description
Concealable Penile Prosthesis, 2 Cylinders FDA UDI

Identifiers

Primary DI / UDI-DI
00878953005249 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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 14 Millimeter FDA UDI
Length — 16 Centimeter FDA UDI

Category: Rigid penile prosthesis

Spectra by American Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid penile prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Medical Systems, Inc.

Sources (1)

  • FDA UDI 85e358ad-b5a9-4c6d-8602-65ada0cab176 34 fields · synced May 30, 2026