AMS 700 CX

GUDID 00878953003788

Inflatable Penile Prosthesis Cylinders

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

• Primary Device ID: 00878953003788
• NIH Device Record Key: e866ea55-6726-4c6d-8c86-2b22369564ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 CX
• Version Model Number: 72404271
• 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: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter
• Length: 12 Centimeter
• Outer Diameter: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953003788 [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 CX ]

• 00878953003825: Inflatable Penile Prosthesis Cylinders, 2 Cylinders
• 00878953003818: Inflatable Penile Prosthesis Cylinders, 2 Cylinders
• 00878953003801: Inflatable Penile Prosthesis Cylinders, 2 Cylinders
• 00878953003795: Inflatable Penile Prosthesis Cylinders, 2 Cylinders
• 00878953003788: Inflatable Penile Prosthesis Cylinders
• 00878953003290: Inflatable Penile Prosthesis Cylinders with InhibiZone
• 00878953003283: Inflatable Penile Prosthesis Cylinders with InhibiZone
• 00878953003276: Inflatable Penile Prosthesis Cylinders with InhibiZone
• 00878953003269: Inflatable Penile Prosthesis Cylinders with InhibiZone
• 00878953003252: Inflatable Penile Prosthesis Cylinders with InhibiZone