| Primary Device ID | 00853235007319 |
| NIH Device Record Key | 85f65a2c-fae2-4b70-b75e-1f29426839f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Allograft-ALT |
| Version Model Number | 53150 ALT |
| Catalog Number | 53150 ALT |
| Company DUNS | 834612764 |
| Company Name | HYDROCISION, 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853235007319 [Primary] |
| HRX | Arthroscope |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-08-21 |
| 00853235007333 - HydroCision Console | 2023-11-22 HydroSurgical Console |
| 00853235007005 - TenJet® | 2018-07-06 TenJet® Percutaneous Hydrotenotomy Set |
| 00853235007012 - TenJet® | 2018-07-06 TenJet® Accessory Set |
| 00853235007029 - TenJet® | 2018-07-06 TenJet® Percutaneous Hydrotenotomy Set |
| 00853235007036 - SpineJet® | 2018-07-06 SpineJet® MicroResector |
| 00853235007043 - HydroCision Console | 2018-07-06 HydroCision Console |
| 00853235007050 - SpineJet® | 2018-07-06 SpineJet® Quick Connector |
| 00853235007067 - SpineJet® | 2018-07-06 SpineJet® Percutaneous Hydrodiscectomy Set with Access Set |