Handle MTGBSUB3

GUDID 00841439104200

U-grip hand positioner

MEDTEC, INC.

Radiological arm/leg positioner

• Primary Device ID: 00841439104200
• NIH Device Record Key: 04279cc4-e8a6-4fc2-aea3-5ad1058bf6b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Handle
• Version Model Number: MTGBSUB3
• Catalog Number: MTGBSUB3
• 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: 5.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439104200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973842

FDA Product Code

• IXQ: Table, radiographic, stationary top

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: 2017-08-02

On-Brand Devices [Handle]

• 00841439104200: U-grip hand positioner
• 00841439104194: Arm up T-grip positioner