| Primary Device ID | 00878953000381 |
| NIH Device Record Key | 06b4dca0-7253-498e-a83f-343f628e2a3e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 0010-0991 |
| Company DUNS | 796308653 |
| Company Name | AMERICAN MEDICAL SYSTEMS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00878953000381 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00878953000381]
Moist Heat or Steam Sterilization
| 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 |