Spectra

GUDID 00878953005294

Concealable Penile Prosthesis, 2 Cylinders

AMERICAN MEDICAL SYSTEMS, INC.

Rigid penile prosthesis

• Primary Device ID: 00878953005294
• NIH Device Record Key: 366510c4-0e0b-464b-b902-8dd2bd2639a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectra
• Version Model Number: 720074-03
• Company DUNS: 125111448
• Company Name: AMERICAN MEDICAL SYSTEMS, INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953005294 [Primary]
GS1	00878953008943 [Unit of Use]

FDA Product Code

• FAE: Prosthesis, Penile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2016-08-12

On-Brand Devices [Spectra ]

• 00878953005294: Concealable Penile Prosthesis, 2 Cylinders
• 00878953005287: Concealable Penile Prosthesis, 2 Cylinders
• 00878953005270: Concealable Penile Prosthesis, 2 Cylinders
• 00878953005256: Concealable Penile Prosthesis, 2 Cylinders
• 00878953005249: Concealable Penile Prosthesis, 2 Cylinders
• 00878953005232: Concealable Penile Prosthesis, 2 Cylinders
• 00878953005225: Concealable Penile Prosthesis, 2 Cylinders
• 00878953005218: Concealable Penile Prosthesis, 2 Cylinders
• 00878953005201: Concealable Penile Prosthesis 2 Cylinders