| Primary Device ID | H66809219451 |
| NIH Device Record Key | e10ae5a0-9e58-4a70-b359-78247868ff78 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bosworth Original Truliner |
| Version Model Number | 0921945 |
| Catalog Number | 0921945 |
| Company DUNS | 014769301 |
| Company Name | Harry J Bosworth Company |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com |
| Weight | 227 Gram |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of direct sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H66809219451 [Primary] |
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-08-09 |
| Device Publish Date | 2016-09-15 |
| H66809219601 | Qt Orig Truliner Liquid |
| H66809219591 | 5 lb Orig Truliner PMMA Pwd Clear |
| H66809219581 | 5 lb Orig Truliner PMMA Pwd Vein |
| H66809219571 | 5 lb Orig Truliner PMMA Pwd Pink |
| H66809219521 | 1 lb bulk Orig Truliner PMMA P&L Kit Vein |
| H66809219511 | 1 lb bulk Orig Truliner PMMA P&L Kit Pink |
| H66809219501 | Orig Truliner Liquid |
| H66809219481 | Orig Truliner PMMA Pwd Vein |
| H66809219471 | Orig Truliner PMMA Pwd Pink |
| H66809219461 | Orig Truliner Liquid |
| H66809219451 | Orig Truliner PMMA Pwd Clear |
| H66809219441 | Orig Truliner PMMA Pwd Vein |
| H66809219431 | Orig Truliner PMMA Pwd Pink |
| H66809219421 | Orig Truliner PMMA Standard P&L Kit Clear |
| H66809219411 | Orig Truliner PMMA Standard P&L Kit Vein |
| H66809219401 | Orig Truliner PMMA Standard P&L Kit Pink |