ParaPost Fiber Lux

GUDID D66160018572C0

PARAPOST FIBER LUX 10 PK SIZE 5.5

COLTENE/WHALEDENT INC

Root canal post, preformed
Primary Device IDD66160018572C0
NIH Device Record Keyca90da14-4274-4458-b830-18d7d1933a4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameParaPost Fiber Lux
Version Model Number60018572C
Company DUNS622185718
Company NameCOLTENE/WHALEDENT INC
Device Count10
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com
Phone3309168800
Emailinfo@coltene.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD66160018572C0 [Unit of Use]
HIBCCD66160018572C1 [Primary]

FDA Product Code

ELRPost, Root Canal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


[D66160018572C0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-24
Device Publish Date2021-03-16

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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