| Primary Device ID | B800933125 |
| NIH Device Record Key | 5dedda8f-ecf9-4c9c-b959-130137704b9f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lead Level 2 |
| Version Model Number | 93312 |
| Catalog Number | 93312 |
| Company DUNS | 092519016 |
| Company Name | UTAK LABORATORIES, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 888-882-5522 |
| welovecontrol@utak.com |
| Total Volume | 3 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B800933120 [Primary] |
| HIBCC | B800933125 [Package] Contains: B800933120 Package: Box [5 Units] In Commercial Distribution |
| DIF | Drug Mixture Control Materials |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-23 |
| Device Publish Date | 2020-04-15 |
| B800933125 | Lead Level 2 |
| B800LEAD2WBFUMMC5 | LEAD LEVEL 2 |
| B800LEAD2WBVWDL5 | LEAD LEVEL 2 |
| B800LEAD2WBFUCI5 | LEAD LEVEL 2 |
| B800LEAD2WBFLGC5 | LEAD LEVEL 2 |
| B800LEAD2WBFBCH5 | LEAD LEVEL 2 |