Precise Bite™ MTCBPBITE

GUDID 00841439104064

Mouthpiece

MEDTEC, INC.

Radiological head/neck positioning mouthpiece

• Primary Device ID: 00841439104064
• NIH Device Record Key: 3938bfb2-a8e4-4fa2-9a92-72f437b35b28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precise Bite™
• Version Model Number: MTCBPBITE
• Catalog Number: MTCBPBITE
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 5
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439104064 [Primary]
GS1	10841439104061 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093738

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-05-31
• Device Publish Date: 2017-08-02

On-Brand Devices [Precise Bite™]

• 00841439104095: Mouthpiece (small) with tongue depressor
• 00841439104088: Mouthpiece with tongue depressor
• 00841439104071: Mouthpiece (small)
• 00841439104064: Mouthpiece