| Primary Device ID | 20634624175338 |
| NIH Device Record Key | 230794e2-2ad1-4763-bef6-3fca9dfeb98b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aortotomy System Lancet 3.3mm |
| Version Model Number | ALX33 |
| Company DUNS | 041810693 |
| Company Name | QUEST MEDICAL INC |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634624175334 [Primary] |
| GS1 | 20634624175338 [Package] Contains: 00634624175334 Package: [25 Units] In Commercial Distribution |
| DWS | Instruments, Surgical, Cardiovascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-18 |
| Device Publish Date | 2019-10-10 |
| 20634624530380 - MPS 3 ISO Medical Air Hose Kit | 2023-10-24 |
| 20634624530397 - MPS 3 Drug Pump Cover | 2023-04-03 |
| 20634624101153 - Q2 IV Administration Set | 2022-12-14 |
| 20634624101252 - Q2 IV Administration Set | 2022-12-14 |
| 20634624101306 - Q2 IV Administration Set | 2022-12-14 |
| 20634624601257 - Q2 IV Administration Set | 2022-12-14 |
| 20634624921096 - High-Flow 4-Way Stopcock | 2022-12-14 |
| 20634624921102 - High-Flow 4-Way Stopcock | 2022-12-14 |