AMS 700 LG MS Pump

GUDID 00878953005782

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

AMERICAN MEDICAL SYSTEMS, INC.

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• Primary Device ID: 00878953005782
• NIH Device Record Key: a4835d4f-1b7f-47f3-aba7-04e9118b75d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 LG MS Pump
• Version Model Number: 72404308
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953005782 [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

Devices Manufactured by AMERICAN MEDICAL SYSTEMS, INC.

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