AMS 700 LGX MS Pump

GUDID 00878953009810

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

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

• Primary Device ID: 00878953009810
• NIH Device Record Key: 87de895f-eb48-4798-8dd2-8782edd2b206
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 LGX MS Pump
• Version Model Number: 72404252-10
• 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: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 18 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953009810 [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: 7
• 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