MoldCARE Cushion Trapezoid

GUDID 09120074396463

IT-V Medizintechnik GmbH

Radiological whole-body positioner

• Primary Device ID: 09120074396463
• NIH Device Record Key: 979a0a90-3c50-45f8-8974-5c8fa5eb0a52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MoldCARE Cushion Trapezoid
• Version Model Number: P10107-646
• Company DUNS: 300005408
• Company Name: IT-V Medizintechnik GmbH
• Device Count: 20
• DM Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120074390904 [Unit of Use]
GS1	09120074396463 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081218

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: 7
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-09-01

Devices Manufactured by IT-V Medizintechnik GmbH

• 09120074395305 - Hand Grip Plate for Elekta: 2024-03-19
• 09120074396746 - U7 Indexing Bar MR Glasfaser for Elekta: 2024-03-19
• 09120074396753 - U14 Indexing Bar MR Glasfaser for Varian: 2024-03-19
• 09120074392625 - Pillow Prone Small Z - MR: 2023-06-23
• 09120074396739 - CT STEP Basic Module 2,4m for Varian: 2022-05-18
• 09120074397576 - System TBI STEP 2,4m: 2022-05-18
• 09120074397583 - System TBI STEP 2,4m for Varian: 2022-05-03
• 09120074395145 - BreastSTEP Prone Tilt Adapter: 2022-04-28