AMS 700 LGX™ TENACIO™ Pump 72404408

GUDID 00191506021283

Inflatable Penile Prosthesis, Preconnected-Infrapubic

BOSTON SCIENTIFIC CORPORATION

Inflatable penile prosthesis

• Primary Device ID: 00191506021283
• NIH Device Record Key: bffabffb-d7e3-47fd-aefc-4cf4a677453d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700 LGX™ TENACIO™ Pump
• Version Model Number: 72404408
• Catalog Number: 72404408
• 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: false
• 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	00191506021283 [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]

• 00191506021283: Inflatable Penile Prosthesis, Preconnected-Infrapubic
• 00191506021276: Inflatable Penile Prosthesis, Preconnected-Infrapubic
• 00191506021269: Inflatable Penile Prosthesis, Preconnected-Infrapubic
• 00191506021252: Inflatable Penile Prosthesis, Preconnected-Infrapubic