MEDRAD® TMJ Positioning Device and Mouthpeices TMJ 200

GUDID 00616258009322

" Burnett BiDirectional TMJ Position Device (TMJ DEVICE,TMJ-200,ASSEMBLED) (59900718)"

BAYER MEDICAL CARE INC.

Facebow

• Primary Device ID: 00616258009322
• NIH Device Record Key: 06464ed6-11e7-486c-9082-5ece9ed11fe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® TMJ Positioning Device and Mouthpeices
• Version Model Number: TMJ 200
• Catalog Number: TMJ 200
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258009322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870243

FDA Product Code

• EAG: Cephalometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [MEDRAD® TMJ Positioning Device and Mouthpeices]

• 00616258009339: " Burnett BiDirectional TMJ Position Device (BI-DIRECTIONAL TMJ DEVICE,PACKAGED) (85104489)"
• 00616258009322: " Burnett BiDirectional TMJ Position Device (TMJ DEVICE,TMJ-200,ASSEMBLED) (59900718)"
• 10616258009312: " TMJ Device Disposable Mouth Pieces (MOUTHPIECES,REPLACEMENT,TMJ,MC) (85104470)"