AMS 700 LGX

GUDID 00878953003962

Inflatable Penile Prosthesis Cylinders, 2 Cylinders

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

• Primary Device ID: 00878953003962
• NIH Device Record Key: b7ddceeb-fab3-4a00-8728-6f7830231363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 LGX
• Version Model Number: 72404294
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953003962 [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: 2014-09-25

On-Brand Devices [AMS 700 LGX]

• 00878953003962: Inflatable Penile Prosthesis Cylinders, 2 Cylinders
• 00878953003955: Inflatable Penile Prosthesis Cylinders, 2 Cylinders
• 00878953003948: Inflatable Penile Prosthesis Cylinders, 2 Cylinders
• 00878953003931: Inflatable Penile Prosthesis Cylinders, 2 Cylinders
• 00878953003566: Inflatable Penile Prosthesis Cylinders, InhibiZone
• 00878953003559: Inflatable Penile Prosthesis Cylinders, InhibiZone
• 00878953003542: Inflatable Penile Prosthesis Cylinders, InhibiZone
• 00878953003535: Inflatable Penile Prosthesis Cylinders, InhibiZone