Immobilizer MTDLI2

GUDID 00841439111567

dual leg

MEDTEC, INC.

Radiological arm/leg positioner

• Primary Device ID: 00841439111567
• NIH Device Record Key: ea780788-06a5-4e70-858c-ae3c6a070802
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Immobilizer
• Version Model Number: MTDLI2
• Catalog Number: MTDLI2
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

• Length: 33.2 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439111567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060737

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: 7
• Public Version Date: 2020-03-19
• Device Publish Date: 2018-03-01

On-Brand Devices [Immobilizer]

• 00841439111574: dual low leg
• 00841439111567: dual leg
• 00841439104187: Reusable non-sterile (84 x 46 x 28cm) dual leg immobilizer
• 00841439104170: Reusable non-sterile (84 x 46 x 28cm) dual leg immobilizer