AMS 700 CXR

GUDID 00878953002675

Inflatable Penile Prosthesis Cylinders

AMERICAN MEDICAL SYSTEMS, INC.

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• Primary Device ID: 00878953002675
• NIH Device Record Key: e0b81098-c032-4557-825c-9e9f2ceb7d2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 CXR
• Version Model Number: 72404010
• 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

• Length: 10 Centimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter
• Outer Diameter: 9.5 Millimeter
• Length: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953002675 [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: 4
• Public Version Date: 2019-02-13
• Device Publish Date: 2014-09-25

On-Brand Devices [AMS 700 CXR]

• 00878953002712: Inflatable Penile Prosthesis Cylinders
• 00878953002705: Inflatable Penile Prosthesis Cylinders
• 00878953002699: Inflatable Penile Prosthesis Cylinders
• 00878953002682: Inflatable Penile Prosthesis Cylinders
• 00878953002675: Inflatable Penile Prosthesis Cylinders