AMS 700™ with TENACIO™ Pump Accessory Kit 72404850

GUDID 00191506021696

Inflatable Penile Prosthesis Accessory Kit

BOSTON SCIENTIFIC CORPORATION

Penile prosthesis implantation kit

• Primary Device ID: 00191506021696
• NIH Device Record Key: dd8d1d3d-f1cb-4753-8751-14317903ec0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS 700™ with TENACIO™ Pump Accessory Kit
• Version Model Number: 72404850
• Catalog Number: 72404850
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00191506021696 [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

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 00191506046330 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046347 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046354 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046361 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046378 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046385 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046392 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046408 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter