Body Pro-Lok ONE™ System BPL100

GUDID 00841439102336

Reusable non-sterile ONEPlatform with lok-bar, ONEBridge, storage base, respiratory belt, repiratory plate, clam-lok cusion, kneefix cushion, and feetfix cushion

MEDTEC, INC.

Radiological whole-body positioner

• Primary Device ID: 00841439102336
• NIH Device Record Key: 2110069e-16a0-4f58-befe-dd429b683642
• Commercial Distribution Discontinuation: 2019-03-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Body Pro-Lok ONE™ System
• Version Model Number: BPL100
• Catalog Number: BPL100
• 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: 72 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439102336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111340

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: 2019-05-23
• Device Publish Date: 2017-08-02

On-Brand Devices [Body Pro-Lok ONE™ System]

• 00841439102343: Bpl One Bridge System, Multi
• 00841439102336: Reusable non-sterile ONEPlatform with lok-bar, ONEBridge, storage base, respiratory belt, repira