AMS 700 CXR RTE Kit

GUDID 00878953002774

Rear Tip Extender Kit, 2 Each 4.0 cm, 5.0 cm, 6.0 cm

AMERICAN MEDICAL SYSTEMS, INC.

Inflatable penile prosthesis

• Primary Device ID: 00878953002774
• NIH Device Record Key: e8a3f914-bd78-4dc5-8354-bc514f44fe2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 CXR RTE Kit
• Version Model Number: 72404043
• 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: 4 Centimeter
• Length: 4 Centimeter
• Length: 4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00878953002774 [Primary]

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: 2019-10-11
• Device Publish Date: 2014-09-24

On-Brand Devices [AMS 700 CXR RTE Kit]

• 00878953002774: Rear Tip Extender Kit, 2 Each 4.0 cm, 5.0 cm, 6.0 cm
• 00878953002408: Rear Tip Extender Kit 2 Each: 0.5 cm, 1.0 cm, 1.5 cm, 2.0 cm, 3.0 cm