Primary Device ID | H66809219501 |
NIH Device Record Key | d71138bc-0c7a-4021-b503-a897d8c84762 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bosworth Original Truliner |
Version Model Number | 0921950 |
Catalog Number | 0921950 |
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 |
Total Volume | 8 Fluid Ounce |
Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | H66809219501 [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 |