Thermoplastic Frame MTSNT3

GUDID 00841439107744

Stereotactic frame

MEDTEC, INC.

Patient positioner base plate

• Primary Device ID: 00841439107744
• NIH Device Record Key: a37aeddd-d114-4146-a969-f9305583fd6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermoplastic Frame
• Version Model Number: MTSNT3
• Catalog Number: MTSNT3
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• 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 Dimensions

• Width: 9.4 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439107744 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080072

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: 2020-03-19
• Device Publish Date: 2017-08-29

On-Brand Devices [Thermoplastic Frame]

• 00841439103814: Reloadable Uni-frame® base
• 00841439107133: Reloadable non-sterile thermoplastic frame set
• 00841439107010: Reloadable non-sterile thermoplastic frame set for use with HipFix®
• 00841439106518: For use with lateral baseplate
• 00841439104118: Reloadable Type-S™ frame with Safe-T pins (5)
• 00841439102008: Reloadable pediatric Type-S™ frame
• 00841439107744: Stereotactic frame
• 00841439107126: Reloadable non-sterile thermoplastic frame set