Clamp BPL006

GUDID 00841439102329

Uct Rail Clamp For Resp. Belt

MEDTEC, INC.

Radiological whole-body positioner

• Primary Device ID: 00841439102329
• NIH Device Record Key: dda551d4-25c0-4c3d-bcdb-6aa0d1511506
• Commercial Distribution Discontinuation: 2019-05-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Clamp
• Version Model Number: BPL006
• Catalog Number: BPL006
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 5.3 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439102329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111340

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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 [Clamp]

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