AMS 700™ TENACIO™ Pump 72404420
GUDID 00191506021290
Inflatable Penile Prosthesis Pump
BOSTON SCIENTIFIC CORPORATION
Inflatable penile prosthesis| Primary Device ID | 00191506021290 |
| NIH Device Record Key | d7ad60d3-1369-4970-af17-54ea48615d8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMS 700™ TENACIO™ Pump |
| Version Model Number | 72404420 |
| Catalog Number | 72404420 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191506021290 [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
| 08714729877769 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877776 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877783 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877806 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877813 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877820 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877837 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
| 08714729877844 - Orbiter™ ST | 2024-12-20 Bidirectional Steerable Diagnostic Catheter |
Trademark Results [AMS 700]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AMS 700 78763908 3282570 Live/Registered |
BOSTON SCIENTIFIC SCIMED, INC. 2005-11-30 |
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