AMS 700 LGX MS Pump

GUDID 00878953009827

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

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

• Primary Device ID: 00878953009827
• NIH Device Record Key: 505c6137-773c-4ee5-82ef-f08030e1ae70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 LGX MS Pump
• Version Model Number: 72404253-12
• 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

• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 21 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953009827 [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: 8
• Public Version Date: 2019-04-03
• Device Publish Date: 2018-01-26

On-Brand Devices [AMS 700 LGX MS Pump]

• 00878953009872: Inflatable Penile Prosthesis, Preconnected - Penoscrotal, 1 Pump, 2 Cylinders
• 00878953009865: Inflatable Penile Prosthesis, Preconnected - Penoscrotal, 1 pump 2 cylinders
• 00878953009827: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal - 1 Pump, 2 Cylinders
• 00878953009810: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal - 1 Pump, 2 Cylinders
• 00878953005775: Inflatable Penile Prosthesis, Preconnected - Infrapubic, 1 pump 2 cylinders
• 00878953005768: Inflatable Penile Prosthesis, Preconnected - Infrapubic, 1 pump 2 cylinders
• 00878953005751: Inflatable Penile Prosthesis, Preconnected - Penoscrotal, 1 pump 2 cylinders
• 00878953005744: Inflatable Penile Prosthesis, Preconnected - Penoscrotal, 1 pump 2 cylinders
• 00878953005737: Inflatable Penile Prosthesis, Preconnected - Penoscrotal, 1 Pump, 2 Cylinders
• 00878953005720: Inflatable Penile Prosthesis, Preconnected - Penoscrotal - 1 pump, 2 cylinders
• 00878953005713: Inflatable Penile Prosthesis, Preconnected - Penoscrotal, 1 pump 2 cylinders
• 00878953003665: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump, 2 Cylinders
• 00878953003658: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump, 2 Cylinders
• 00878953003641: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump, 2 Cylinders
• 00878953003634: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic 1 Pump, 2 Cylinders
• 00878953003603: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump, 2 Cylinders
• 00878953003597: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump, 2 Cylinders
• 00878953003580: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump, 2 Cylinders