| Primary Device ID | 08426950453482 |
| NIH Device Record Key | 79227598-fccc-48f8-9c64-a95c65aa04df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACL ELITE PRO |
| Version Model Number | 00001000311R |
| Catalog Number | 00001000311R |
| Company DUNS | 557223252 |
| Company Name | INSTRUMENTATION LABORATORY COMPANY |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 08426950453482 [Primary] |
| JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2016-09-23 |
| 08426950453482 | ACL ELITE PRO (Refurbished) |
| 08426950451570 | ACL ELITE PRO |