AMS 700 LGX MS Pump

GUDID 00878953005737

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

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

• Primary Device ID: 00878953005737
• NIH Device Record Key: 2691559b-d226-4698-bf33-f19e833d236b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 LGX MS Pump
• Version Model Number: 72404302
• 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: 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

• Outer Diameter: 12 Millimeter
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953005737 [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: 5
• Public Version Date: 2019-02-13
• Device Publish Date: 2014-09-24

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• 00878953005775: Inflatable Penile Prosthesis, Preconnected - Infrapubic, 1 pump 2 cylinders
• 00878953005768: Inflatable Penile Prosthesis, Preconnected - Infrapubic, 1 pump 2 cylinders
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• 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
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• 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