| Primary Device ID | B5850P9PT09SYS0 |
| NIH Device Record Key | 0c01aa92-36cf-4c04-b1be-ae848e9b4ff2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PT9 |
| Version Model Number | 0P9PT09SYS |
| Catalog Number | 0P9PT09SYS |
| Company DUNS | 847899911 |
| Company Name | THERMOTEK, 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com | |
| Phone | 972-874-4949 |
| info@thermotekusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B5850P9PT09SYS0 [Primary] |
| JOW | Sleeve, Limb, Compressible |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-12 |
| Device Publish Date | 2019-03-04 |
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