ONEPlatform™ - Short BPL004

GUDID 00841439102305

ONEPlatform™ - Short

MEDTEC, INC.

Radiological whole-body positioner

• Primary Device ID: 00841439102305
• NIH Device Record Key: 0af9e377-a817-46d8-95cc-b516a5ee22fb
• Commercial Distribution Discontinuation: 2020-01-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ONEPlatform™ - Short
• Version Model Number: BPL004
• Catalog Number: BPL004
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00841439102305 [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: 9
• Public Version Date: 2020-01-02
• Device Publish Date: 2017-08-02

Devices Manufactured by MEDTEC, INC.

• 00841439114650 - Pronumbra: 2025-09-22 Pronumbra Helping Hand, Left
• 00841439114674 - Pronumbra: 2025-09-22 Pronumbra Helping Hand, Right
• 00841439114681 - Pronumbra: 2025-09-22 Pronumbra 130cm kVue
• 00841439114698 - Pronumbra: 2025-09-22 Pronumbra Neck Support, 40mm
• 00841439114704 - Pronumbra: 2025-09-22 Pronumbra Neck Support, 50mm
• 00841439114711 - Pronumbra: 2025-09-22 Pronumbra Neck Support, 65mm
• 00841439114728 - Pronumbra: 2025-09-22 Pronumbra Shoulder Adapter
• 00841439114841 - ZiFix Traverse: 2025-09-22 ZiFix Traverse with ONEClamp