| Primary Device ID | 00878953003054 |
| NIH Device Record Key | 3e0a783c-0cf7-4662-a1ae-1d25223b551e |
| Commercial Distribution Discontinuation | 2019-01-23 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AMS 700 |
| Version Model Number | 72404123 |
| Company DUNS | 125111448 |
| Company Name | AMERICAN MEDICAL SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00878953003054 [Primary] |
| JCW | Prosthesis, Penis, Inflatable |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00878953003054]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-02-13 |
| Device Publish Date | 2014-09-25 |
| 00878953003054 | IPP Surgical Tool System 1 AMS Connector Tool 1 AMS Insertion Package 1 AMS Furlow Cylinder In |
| 00878953002439 | Tactile Pump with InhibiZone |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMS 700 78763908 3282570 Live/Registered |
BOSTON SCIENTIFIC SCIMED, INC. 2005-11-30 |