JMA Optic NA

GUDID B915015700101

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

zebris MEDICAL GmbH

Facebow

• Primary Device ID: B915015700101
• NIH Device Record Key: fb76e9a7-efda-4467-912d-29410f1484b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JMA Optic
• Version Model Number: 01570010
• Catalog Number: NA
• Company DUNS: 328971791
• Company Name: zebris MEDICAL GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4975629726300
• Email: support@zebris.de
• Phone: +4975629726300
• Email: support@zebris.de
• Phone: +4975629726300
• Email: support@zebris.de
• Phone: +4975629726300
• Email: support@zebris.de
• Phone: +4975629726300
• Email: support@zebris.de
• Phone: +4975629726300
• Email: support@zebris.de
• Phone: +4975629726300
• Email: support@zebris.de
• Phone: +4975629726300
• Email: support@zebris.de

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B915015700101 [Primary]

FDA Product Code

• NFS: Device, Jaw Tracking, For Monitoring Jaw Positions

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B915015700101]

Moist Heat or Steam Sterilization

[B915015700101]

Moist Heat or Steam Sterilization

[B915015700101]

Moist Heat or Steam Sterilization

[B915015700101]

Moist Heat or Steam Sterilization

[B915015700101]

Moist Heat or Steam Sterilization

[B915015700101]

Moist Heat or Steam Sterilization

[B915015700101]

Moist Heat or Steam Sterilization

[B915015700101]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-23
• Device Publish Date: 2021-08-15

On-Brand Devices [JMA Optic]

• B915015700101: Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and
• B915011700100: Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements
• B915015700111: Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and
• B915011700110: Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements