| Primary Device ID | 00310866000152 | 
| NIH Device Record Key | 979c18c1-7dc4-495c-a049-1d2235567a58 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Oratip II Kit Dispoable Oral Evacuation Tips - 50 tips | 
| Version Model Number | 24205 | 
| Catalog Number | 24205 | 
| Company DUNS | 009260217 | 
| Company Name | PASCAL COMPANY, INC. | 
| Device Count | 50 | 
| 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 | 
| Phone | 8004268051 | 
| pascal@pascaldental.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00310866000152 [Primary] | 
| GS1 | 00310866002040 [Unit of Use] | 
| EHZ | Evacuator, Oral Cavity | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-03-04 | 
| Device Publish Date | 2019-01-30 | 
| 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. |