ParaPost Fiber Lux

GUDID D661PF17151

5 ParaPost FiberLux Posts, Size 5

COLTENE/WHALEDENT INC

Root canal post, preformed
Primary Device IDD661PF17151
NIH Device Record Key2e0f8871-ff66-44d3-b008-d9f97a4f3240
Commercial Distribution StatusIn Commercial Distribution
Brand NameParaPost Fiber Lux
Version Model NumberPF1715
Company DUNS622185718
Company NameCOLTENE/WHALEDENT INC
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840016201707 [Secondary]
HIBCCD661PF17150 [Unit of Use]
HIBCCD661PF17151 [Primary]

FDA Product Code

ELRPost, Root Canal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


[D661PF17151]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-18
Device Publish Date2019-02-11

On-Brand Devices [ParaPost Fiber Lux]

D661PF170C0PARAPOST FIBER LUX INTRO KIT
D66160018573C0PARAPOST FIBER LUX 10 PK SIZE 6
D66160018572C0PARAPOST FIBER LUX 10 PK SIZE 5.5
D66160018571C0PARAPOST FIBER LUX 10 PK SIZE 5
D66160018570C0PARAPOST FIBER LUX 10 PK SIZE 4.5
D66160018569C0PARAPOST FIBER LUX 10 PK SIZE 4
D66160018568C0PARAPOST FIBER LUX 10 PK SIZE 3
D661PF171615 ParaPost FiberLux Posts, Size 6
D661PF1715515 ParaPost FiberLux Posts, Size 5.5
D661PF171515 ParaPost FiberLux Posts, Size 5
D661PF1714515 ParaPost FiberLux Posts, Size 4.5
D661PF171415 ParaPost FiberLux Posts, Size 4
D661PF171315 ParaPost FiberLux Posts, Size 3
D661PF1701ParaPost FiberLux Intro Kit
D661600199080ParaPost Fiber Lux Training Kit
D661600185730ParaPost Fiber Lux Size 6
D661600185720ParaPost Fiber Lux Size 5.5
D661600185710ParaPost Fiber Lux Size 5
D661600185700ParaPost Fiber Lux Size 4.5
D661600185690ParaPost Fiber Lux Size 4
D661600185680ParaPost Fiber Lux Size 3

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