| Primary Device ID | B461JAU11591 |
| NIH Device Record Key | d9cc7d3a-51a0-4614-93ae-6fcd24c41310 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Jac-cell USA In.c |
| Version Model Number | JAU-1159 |
| Company DUNS | 015023538 |
| Company Name | JAC CELL USA INC |
| Device Count | 10 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B461JAU115909 [Unit of Use] |
| HIBCC | B461JAU11591 [Primary] |
| BYY | Tube, Aspirating, Flexible, Connecting |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-27 |
| B461JAU142000 - Jac-cell USA | 2019-02-07 Disposable PTFE Coated Blade Electrode - Shrink Wrap Insulated, ETO Sterile |
| B461JAU142011 - Jac-cell USA | 2019-02-07 Disposable PTFE Coated Blade Electrode - Shrink Wrap Insulated, ETO Sterile |
| B461JAU142213 - Jac-cell USA Inc. | 2019-02-07 PENCIL, Push Button w/SS Blade&Holster Disposable |
| B461JAU15201 - Jac-cell USA Inc. | 2019-02-07 Disposal standard blade electrode |
| B461JAU97971 - Jac-cell USA Inc. | 2018-07-06 SAF-T-VAC Smoke and Fluid Evacuator |
| B461JAU11591 - Jac-cell USA In.c | 2018-03-29Aspiration Tubing |
| B461JAU11591 - Jac-cell USA In.c | 2018-03-29 Aspiration Tubing |
| B461JAU116012 - Jac-cell USA Inc | 2018-03-29 Liposuction Tubing |
| B461JAU11681 - Jac-cell USA Inc. | 2018-03-29 Infiltration tubing for peristaltic pumps |