| Primary Device ID | 10858835007889 |
| NIH Device Record Key | cf997943-dbe8-4165-b7be-012a507217df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biotronix Healthcare Cotton Cast Padding |
| Version Model Number | PO2002 |
| Catalog Number | PO2002 |
| Company DUNS | 065762392 |
| Company Name | BIOTRONIX HEALTHCARE INDUSTRIES, 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com | |
| Phone | 786-473-9436 |
| mborges@biotronixhealthcare.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858835007882 [Primary] |
| GS1 | 10858835007889 [Package] Contains: 00858835007882 Package: Case [6 Units] In Commercial Distribution |
| ITG | Bandage, Cast |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-12-24 |
| Device Publish Date | 2019-10-22 |
| 10858835007889 | Cotton Cast Padding, 3" x 4.1yds, 12 Rolls/Bag |
| 10858835007865 | Cotton Cast Padding, 2" x 4.1yds, 24 Rolls/Bag |
| 10858835007902 | Cotton Cast Padding, 6" x 4.1yds, 12 Rolls/Bag |
| 00858835007899 | Cotton Cast Padding, 4" x 4.1yds, 12 Rolls/Bag, |