| Primary Device ID | 00310866000534 | 
| NIH Device Record Key | b311853d-0dd4-4614-afd3-d69e7f575d31 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Racord Retraction Cord 8/0 | 
| Version Model Number | 07700 | 
| Catalog Number | 07700 | 
| 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 | true | 
| 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 | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | |
| Phone | 8004268051 | 
| pascal@pascaldental.com | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00310866000534 [Primary] | 
| MVL | Cord, Retraction | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-03-01 | 
| Device Publish Date | 2019-01-29 | 
| 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. |