Primary Device ID | D661PF17141 |
NIH Device Record Key | 3182126a-63a7-4f24-89bb-5920e731441d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ParaPost Fiber Lux |
Version Model Number | PF1714 |
Company DUNS | 622185718 |
Company Name | COLTENE/WHALEDENT INC |
Device Count | 5 |
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 | 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 | 00840016201684 [Secondary] |
HIBCC | D661PF17140 [Unit of Use] |
HIBCC | D661PF17141 [Primary] |
ELR | Post, Root Canal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
[D661PF17141]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-09-18 |
Device Publish Date | 2019-02-11 |
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 |