AMS 700 CX MS Pump

GUDID 00878953009780

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

AMERICAN MEDICAL SYSTEMS, INC.

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• Primary Device ID: 00878953009780
• NIH Device Record Key: b29e61dd-e10c-43c0-b091-fbccd6e313f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 CX MS Pump
• Version Model Number: 72404232-10
• 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
• 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	00878953009780 [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: 2019-04-04
• Device Publish Date: 2018-01-26

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• 00878953003924: Inflatable Penile Prosthesis, Preconnected - Infrapubic 1 pump, 2 cylin
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• 00878953003450: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal -1 Pump, 2 Cylinders
• 00878953003443: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal- 1 Pump, 2 Cylinders
• 00878953003436: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal 1 Pump 2 Cylinders