AccessGUDID - DEVICE: Spectra (00878953005201)

GUDID

Device Identifier (DI) Information

Brand Name: Spectra
Version or Model: 720054-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: AMERICAN MEDICAL SYSTEMS, INC.

Primary DI Number: 00878953005201
Issuing Agency: GS1
Commercial Distribution End Date: July 06, 2025
Device Count: 2
Labeler D-U-N-S® Number*: 125111448 *Terms of Use

Device Description: Concealable Penile Prosthesis 2 Cylinders

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36251	Rigid penile prosthesis	A rigid or semi-rigid sterile rod or cylinder-like device intended to be surgically implanted in the corpora cavernosa of the penis in a patient with erectile dysfunction (ED) [commonly known as impotence] in order to achieve permanent penile tumescence and rigidity adequate for vaginal intercourse. This device is available in a variety of designs and materials such as: 1) a flexible solid rod of polymer; 2) a flexible polymer or silicone cylinder with an internal silver (Ag) coil core; or 3) a single- or multiple-hinged rod enabling the user to position the penis downwards for better concealment under clothing.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FAE	Prosthesis, Penile

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 12 Centimeter
Outer Diameter: 9.5 Millimeter

Device Record Status

Public Device Record Key: b025eaad-07ba-428f-a9dd-ae304449eaf6
Public Version Date: August 20, 2025
Public Version Number: 5
DI Record Publish Date: August 12, 2016