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 |