| Primary Device ID | D757H722C2F0 |
| NIH Device Record Key | 3bca6e24-2e16-45a4-ad56-6c85a566cb56 |
| Commercial Distribution Discontinuation | 2019-12-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AELITE LS C2 15tips/Fex Tube |
| Version Model Number | H-722C2F |
| Catalog Number | H-722C2F |
| 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 | true |
| 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 | D757H722C2F0 [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 | 2019-12-06 |
| Device Publish Date | 2017-06-12 |
| 00810111542937 - TheraCal PT | 2024-04-11 TheraCal PT 2g Dual Syr |
| 00810111542944 - TheraCal PT | 2024-04-11 TheraCal PT 2g Syr Pkg |
| D757B2501A1 - PRE-BOND Resin 3ml Btl | 2024-02-16 |
| D757B36050 - Ace All-Bond TE Cartrdg(Pouch) | 2024-02-16 |
| D757B36050P1 - Ace All-Bond TE 4 Cartrdg Pkg | 2024-02-16 |
| 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 |