| Primary Device ID | D757A1201P0 |
| NIH Device Record Key | c91ee764-a124-4b49-93fc-8c470be1264d |
| Commercial Distribution Discontinuation | 2019-04-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | BISFIL-II CATALYST 5g Syringe |
| Version Model Number | A-1201P |
| Catalog Number | A-1201P |
| 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 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D757A1201P0 [Primary] |
| EBF | MATERIAL, TOOTH SHADE, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-04-04 |
| Device Publish Date | 2017-06-12 |
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| 00810111542944 - TheraCal PT | 2024-04-11 TheraCal PT 2g Syr Pkg |
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| D757B3605PS1 - ACE-All-Bond TE 1 CartridgePkg | 2024-02-16 |
| D757B36100K1 - ACE All-Bond TE Starter Kit | 2024-02-16 |
| D757B412010 - Ace Universal Primer A&B Cartridge-Pouch | 2024-02-16 |