Primary Device ID | 00810111540797 |
NIH Device Record Key | e7cace1b-a5d6-4de9-8b5d-64c50ea162df |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TheraCal PT |
Version Model Number | H-34010 |
Catalog Number | H-34010 |
Company DUNS | 053529939 |
Company Name | BISCO INC. |
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 | 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(847)534-6000 |
sales@bisco.com |
Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810111540797 [Primary] |
HIBCC | D757H340100 [Previous] |
EJK | Liner, Cavity, Calcium Hydroxide |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-10 |
Device Publish Date | 2022-09-30 |
D757H340100 | TheraCal PT 4g Dual Syr |
00810111540797 | TheraCal PT 4g Dual Syr |
00810111540803 | TheraCal PT 4g Syr Pkg |
00810111542944 | TheraCal PT 2g Syr Pkg |
00810111542937 | TheraCal PT 2g Dual Syr |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() THERACAL PT 88253781 not registered Live/Pending |
Bisco Inc. 2019-01-08 |