AMS 700 CXR RTE Kit

GUDID 00878953002408

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.

Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis

• Primary Device ID: 00878953002408
• NIH Device Record Key: f5a3e839-8e04-498b-b1c5-9b985a94b633
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 CXR RTE Kit
• Version Model Number: 72403872
• 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: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1.5 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953002408 [Primary]

FDA Product Code

• JCW: Prosthesis, Penis, Inflatable

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: 2014-09-24

On-Brand Devices [AMS 700 CXR RTE Kit]

• 00878953002774: Rear Tip Extender Kit, 2 Each 4.0 cm, 5.0 cm, 6.0 cm
• 00878953002408: Rear Tip Extender Kit 2 Each: 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm