PlaneAnalyser II NA

GUDID B915011700710

Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements.

zebris MEDICAL GmbH

Facebow
Primary Device IDB915011700710
NIH Device Record Key753c2bc7-28a9-462a-a2c6-7c0c33663f29
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlaneAnalyser II
Version Model Number01170071
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 Kitfalse
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
Phone+1 800 699 1813
EmailsupportUSA@zirkonzahn.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage 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
HIBCCB915011700710 [Primary]

FDA Product Code

NFSDevice, Jaw Tracking, For Monitoring Jaw Positions

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


[B915011700710]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-26
Device Publish Date2021-02-18

On-Brand Devices [PlaneAnalyser II]

B915015700711Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and
B915011700710Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.