Primary Device ID | 00878953000473 |
NIH Device Record Key | 0b203fca-4208-4fbb-b7f8-f38433e727bd |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 0010-6133 |
Company DUNS | 796308653 |
Company Name | AMERICAN MEDICAL SYSTEMS |
Device Count | 2 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00878953000473 [Primary] |
GS1 | 00878953009391 [Unit of Use] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-02-13 |
Device Publish Date | 2016-09-24 |
00878953004822 - SureFlex 200 | 2019-04-25 200 Lithotripsy Fiber |
00878953000015 - AddStat | 2019-02-13 |
00878953000046 - EndoStat | 2019-02-13 0.2mm 12ft |
00878953000053 - EndoStat | 2019-02-13 0.2mm 12ft SL |
00878953000060 - EndoStat | 2019-02-13 0.3mm 12ft |
00878953000077 - EndoStat | 2019-02-13 0.6mm 12ft |
00878953000084 - EndoStat | 2019-02-13 0.6mm 18ft |
00878953000091 - EndoStat | 2019-02-13 0.6mm 12ft |