| Primary Device ID | H6680921985V1 |
| NIH Device Record Key | f0ac2aa0-d5a9-446c-972f-8774ebfd9121 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bosworth New Truliner |
| Version Model Number | 0921985V |
| Catalog Number | 0921985V |
| 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 | true |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H6680921985V1 [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 |
| H66809219971 | Gal New Truliner Liquid |
| H66809219931 | 5 lb New Truliner PEMA Pwd Clear |
| H66809219921 | 5 lb New Truline PEMA Pwd Vein |
| H66809219911 | 5 lb New Truliner PEMA Pwd Pink |
| H66809219901 | 5 lb New Truliner PEMA P&L Kit Clear |
| H66809219891 | 5 lb New Truliner PEMA P&L Kit Vein |
| H66809219881 | 5 lb New Truliner PEMA P&L Kit Pink |
| H66809219871 | Qt New Truliner Liquid |
| H66809219861 | 8 oz New Truliner Liquid |
| H6680921985V1 | New Truliner PEMA 3 oz P & 1 oz L Mini Kit Vein |
| H6680921985C1 | New Truliner PEMA 3 oz P & 1 oz L Mini Kit Clear |
| H66809219851 | New Truliner PEMA 3 oz P & 1 oz L Mini Kit Pink |
| H66809219841 | 4 oz Bonding Liquid |
| H66809219831 | 1/3 oz Bonding Liquid |
| H66809219801 | 1 lb New Truliner PEMA Pwd Pink |
| H66809219781 | New Truliner 1 lb bulk PEMA P&L Kit Vein |
| H66809219771 | New Truliner 1 lb bulk PEMA P&L Kit Pink |
| H66809219761 | New Truliner Liquid |
| H66809219751 | 8 oz New Truliner PEMA Pwd Clear |
| H66809219741 | 8 oz New Truliner PEMA Pwd Vein |
| H66809219731 | 8 oz New Truliner PEMA Pwd Pink |
| H66809219721 | 8 oz New Truliner P&L Kit Clear |
| H66809219711 | 8 oz New Truliner PEMA P&L Kit Vein |
| H66809219701 | 8 oz New Truliner PEMA P&L Kit Pink |
| H66809217831 | 3 oz New Truliner PEMA Pwd Pink |
| H66809216861 | New Truliner PEMA Liquid |