AMS 700 LGX™ TENACIO™ Pump 72404453

GUDID 00191506021443

Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal

BOSTON SCIENTIFIC CORPORATION

Inflatable penile prosthesis

• Primary Device ID: 00191506021443
• NIH Device Record Key: 0abb14d3-d5f9-450a-9077-2dbf6c7f929a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 LGX™ TENACIO™ Pump
• Version Model Number: 72404453
• Catalog Number: 72404453
• 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: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter
• Length: 21 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506021443 [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 LGX™ TENACIO™ Pump]

• 00191506021481: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
• 00191506021474: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
• 00191506021467: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
• 00191506021450: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Infrapubic
• 00191506021443: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
• 00191506021436: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
• 00191506021429: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
• 00191506021412: Inflatable Penile Prosthesis, InhibiZone/Preconnected - Penoscrotal
• 00191506021245: Inflatable Penile Prosthesis, Preconnected-Penoscrotal
• 00191506021238: Inflatable Penile Prosthesis, Preconnected-Penoscrotal
• 00191506021221: Inflatable Penile Prosthesis, Preconnected-Penoscrotal
• 00191506021214: Inflatable Penile Prosthesis, Preconnected-Penoscrotal