AMS 700 CXR MS Pump

GUDID 00878953003726

Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

• Primary Device ID: 00878953003726
• NIH Device Record Key: 2c0721ad-4f71-4f0c-914b-b4a7063ce93a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 CXR MS Pump
• Version Model Number: 72404264
• 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 Dimensions

• Outer Diameter: 9.5 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 9.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953003726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N970012

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 CXR MS Pump]

• 00878953003771: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump 2 C
• 00878953003764: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic, 1 Pump, 2
• 00878953003757: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump 2 C
• 00878953003740: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic, 1 Pump 2 Cy
• 00878953003733: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump 2 C
• 00878953003726: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders
• 00878953003719: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders
• 00878953003702: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders
• 00878953003696: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders
• 00878953003689: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders