AMS Ambicor RTE Kit

GUDID 00878953001364

Rear Tip Extenders 8 (2 each: 0.5, 1, 2, 3 cm)

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

• Primary Device ID: 00878953001364
• NIH Device Record Key: 96486944-b818-4585-86fd-f1b8ba251946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS Ambicor RTE Kit
• Version Model Number: 72402890
• 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: true
• 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: 0.5 Centimeter
• Length: 0.5 Centimeter
• Length: 0.5 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter
• Length: 3 Centimeter
• Length: 2 Centimeter
• Length: 1 Centimeter
• Length: 0.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953001364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: N970012

FDA Product Code

• FHW: Device, Impotence, Mechanical/Hydraulic

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: 2014-09-24

Devices Manufactured by AMERICAN MEDICAL SYSTEMS, INC.

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• 00878953004051 - Rear Tip Extender: 2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
• 00878953004068 - Rear Tip Extender: 2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
• 00878953004075 - Rear Tip Extender: 2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
• 00878953004082 - Rear Tip Extender: 2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
• 00878953004099 - Rear Tip Extender: 2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
• 00878953004105 - Rear Tip Extender: 2019-06-05 For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis