Plane Analyse DigiPro NA

GUDID B915015700701

Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories

zebris MEDICAL GmbH

Facebow
Primary Device IDB915015700701
NIH Device Record Key6a22d76d-6a66-44b4-9c1c-cac092b5f563
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlane Analyse DigiPro
Version Model Number01570070
Catalog NumberNA
Company DUNS328971791
Company Namezebris MEDICAL GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB915015700701 [Primary]

FDA Product Code

NFSDevice, Jaw Tracking, For Monitoring Jaw Positions

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


[B915015700701]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-02
Device Publish Date2020-11-24

On-Brand Devices [Plane Analyse DigiPro]

B915015700701Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and
B915011700700Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements.

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