| Primary Device ID | D661600185720 |
| NIH Device Record Key | 2f040960-73dd-40b9-bf51-e35539ed69e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ParaPost Fiber Lux |
| Version Model Number | 60018572 |
| Company DUNS | 622185718 |
| Company Name | COLTENE/WHALEDENT INC |
| Device Count | 10 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840016201882 [Secondary] |
| HIBCC | D661600185720 [Unit of Use] |
| HIBCC | D661600185721 [Primary] |
| ELR | Post, Root Canal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
[D661600185720]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-06 |
| Device Publish Date | 2024-11-28 |
| D661PF170C0 | PARAPOST FIBER LUX INTRO KIT |
| D66160018573C0 | PARAPOST FIBER LUX 10 PK SIZE 6 |
| D66160018572C0 | PARAPOST FIBER LUX 10 PK SIZE 5.5 |
| D66160018571C0 | PARAPOST FIBER LUX 10 PK SIZE 5 |
| D66160018570C0 | PARAPOST FIBER LUX 10 PK SIZE 4.5 |
| D66160018569C0 | PARAPOST FIBER LUX 10 PK SIZE 4 |
| D66160018568C0 | PARAPOST FIBER LUX 10 PK SIZE 3 |
| D661PF17161 | 5 ParaPost FiberLux Posts, Size 6 |
| D661PF171551 | 5 ParaPost FiberLux Posts, Size 5.5 |
| D661PF17151 | 5 ParaPost FiberLux Posts, Size 5 |
| D661PF171451 | 5 ParaPost FiberLux Posts, Size 4.5 |
| D661PF17141 | 5 ParaPost FiberLux Posts, Size 4 |
| D661PF17131 | 5 ParaPost FiberLux Posts, Size 3 |
| D661PF1701 | ParaPost FiberLux Intro Kit |
| D661600199080 | ParaPost Fiber Lux Training Kit |
| D661600185730 | ParaPost Fiber Lux Size 6 |
| D661600185720 | ParaPost Fiber Lux Size 5.5 |
| D661600185710 | ParaPost Fiber Lux Size 5 |
| D661600185700 | ParaPost Fiber Lux Size 4.5 |
| D661600185690 | ParaPost Fiber Lux Size 4 |
| D661600185680 | ParaPost Fiber Lux Size 3 |