Spectra RTE Kit

GUDID 00878953005393

Rear Tip Extender Kit 2 Each: 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm

AMERICAN MEDICAL SYSTEMS, INC.

Penile prosthesis extender

• Primary Device ID: 00878953005393
• NIH Device Record Key: 8ec2f502-7a2e-472f-80ab-9d1e26e31bd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectra RTE Kit
• Version Model Number: 720170-01
• Company DUNS: 125111448
• Company Name: AMERICAN MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

• Length: 0.5 Centimeter
• Length: 0.5 Centimeter
• Length: 0.5 Centimeter
• Length: 0.5 Centimeter
• Length: 0.5 Centimeter
• Length: 0.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953005393 [Primary]

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 RTE Kit]

• 00878953005409: Rear Tip Extender Kit 2 Each: 4.0 cm, 5.0 cm, 6.0 cm
• 00878953005393: Rear Tip Extender Kit 2 Each: 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm