AMS 700™ CXR TENACIO™ Pump 72404464

GUDID 00191506021535

Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal

BOSTON SCIENTIFIC CORPORATION

Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis Inflatable penile prosthesis

• Primary Device ID: 00191506021535
• NIH Device Record Key: 9fde6dca-ea79-4ac9-ba26-f3eeb7f7e932
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700™ CXR TENACIO™ Pump
• Version Model Number: 72404464
• Catalog Number: 72404464
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506021535 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-05
• Device Publish Date: 2024-01-26

On-Brand Devices [AMS 700™ CXR TENACIO™ Pump]

• 00191506021580: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
• 00191506021573: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
• 00191506021566: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
• 00191506021559: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
• 00191506021542: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
• 00191506021535: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
• 00191506021528: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
• 00191506021511: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
• 00191506021504: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
• 00191506021498: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal