AMS 700

GUDID 00878953002439

Tactile Pump with InhibiZone

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

• Primary Device ID: 00878953002439
• NIH Device Record Key: 5cb1902b-3225-4ee8-9110-272763ed88fe
• Commercial Distribution Discontinuation: 2016-02-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AMS 700
• Version Model Number: 72403900
• 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: false
• Device Combination Product: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00878953002439 [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: 2014-09-25

On-Brand Devices [AMS 700 ]

• 00878953003054: IPP Surgical Tool System 1 AMS Connector Tool 1 AMS Insertion Package 1 AMS Furlow Cylinder In
• 00878953002439: Tactile Pump with InhibiZone