| Primary Device ID | EJKP100003784A0 |
| NIH Device Record Key | 134183a2-b6e7-4f73-94c8-3daf799c09c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PF TLT 42/3 RS USA |
| Version Model Number | JK 164 / 42-3 TLT |
| Company DUNS | 316232073 |
| Company Name | JK-Products GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EJKP100003784A0 [Primary] |
| LEJ | Booth, Sun Tan |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-21 |
| Device Publish Date | 2022-11-13 |
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