| Primary Device ID | 00310866002187 |
| NIH Device Record Key | a416de29-693b-4316-8a71-0c07b5348251 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Retrax System R-11 |
| Version Model Number | 26111 |
| Catalog Number | 26111 |
| Company DUNS | 009260217 |
| Company Name | PASCAL COMPANY, INC. |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00310866002187 [Primary] |
| EIF | Accessories, Retractor, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
[00310866002187]
Dry Heat Sterilization;Moist Heat or Steam Sterilization;High-level Disinfectant
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-17 |
| Device Publish Date | 2022-05-09 |
| 00310866002552 - KOIS KR-1 PACKER | 2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 0.5MM HEAD |
| 00310866002606 - KOIS KR-2 PACKER | 2024-06-12 RETRACTION CORD PACKING INSTRUMENT INSPIRED BY KOIS 1MM HEAD |
| 00310866002613 - KOIS KR-3 PACKER | 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 1.5MM HEAD |
| 00310866002620 - KOIS KR-4 PACKER | 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2MM HEAD |
| 00310866002637 - KOIS KR-5 PACKER | 2024-06-12 RETRACTION CORD PACKER INSPIRED BY KOIS 2.5MM HEAD |
| 00310866002644 - GET SCULPTED | 2024-05-24 Wax Carving Set |
| 00310866002651 - Fluorilaq Salted Caramel (10mL) Tube | 2024-04-05 5% Sodium Fluoride with Xylitol. No separation, no mixing & no mess. Ideal for hypersensitivity treatments. |
| 00310866002668 - Fluorilaq Mint (10mL) Tube | 2024-04-05 5% Fluoride Varnish with Xylitol. Ideal for cavity varnish. |