MR/X-ray HFD (HFD 210)

GUDID 00857534006004

MR/X-ray Head Fixation Device (HFD210),112634-000

DEERFIELD IMAGING, INC.

Skull clamp

• Primary Device ID: 00857534006004
• NIH Device Record Key: ebaa6b63-b99d-4e8d-90ee-b3ba342820d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR/X-ray HFD (HFD 210)
• Version Model Number: HFD210
• Company DUNS: 079990922
• Company Name: DEERFIELD IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857534006004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113748

FDA Product Code

• HBL: Holder, Head, Neurosurgical (Skull Clamp)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-10

Devices Manufactured by DEERFIELD IMAGING, INC.

• 00857534006837 - Horseshoe Headrest: 2024-11-11 Horseshoe Headrest Starter Kit, HFD 100
• 00857534006844 - Horseshoe Headrest: 2024-11-11 Horseshoe Headrest Starter Kit, HFD 200
• 00857534006271 - VISIUSeye: 2024-10-14 VISIUSeye - iMRI 1.5T E
• 00857534006295 - VISIUSeye: 2024-10-14 VISIUSeye - iMRI 3T V
• 00857534006301 - VISIUSeye: 2024-10-14 VISIUSeye - iCT 64
• 00857534006363 - VISIUSmatrix: 2024-10-14 Application Platform 2.4 NA
• 00857534006455 - MR/X-ray HFD (HFD 200): 2024-10-14 MR/X-ray Head Fixation Device (HFD 200)
• 00857534006585 - VISIUSeye: 2024-10-14 VISIUSeye, iMRI 3T V