Clamp 20SBRT0601

GUDID 00841439110317

Rails-Only System with Varian Exact (53cm)

MEDTEC, INC.

Radiological whole-body positioner

• Primary Device ID: 00841439110317
• NIH Device Record Key: 342a5d00-d0ce-4515-b57f-5b373065c087
• Commercial Distribution Discontinuation: 2019-08-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Clamp
• Version Model Number: 20SBRT0601
• Catalog Number: 20SBRT0601
• 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: 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(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Dimensions

• Length: 10.4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439110317 [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: 2019-08-29
• Device Publish Date: 2017-08-02

On-Brand Devices [Clamp]

• 00841439107584: Clamp
• 00841439107577: Clamp
• 00841439107355: Clamp
• 00841439102329: Uct Rail Clamp For Resp. Belt
• 00841439110317: Rails-Only System with Varian Exact (53cm)