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 |