AMS 700™ TENACIO™ Pump 72404429

GUDID 00191506021306

Inflatable Penile Prosthesis Pump, InhibiZone

BOSTON SCIENTIFIC CORPORATION

Inflatable penile prosthesis

• Primary Device ID: 00191506021306
• NIH Device Record Key: bc765565-bdcc-46d1-86b3-a2c07be5ed10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700™ TENACIO™ Pump
• Version Model Number: 72404429
• Catalog Number: 72404429
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00191506021306 [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

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