MR/X-ray HFD (HFD 200)

GUDID 00857534006455

MR/X-ray Head Fixation Device (HFD 200)

DEERFIELD IMAGING, INC.

Skull clamp

• Primary Device ID: 00857534006455
• NIH Device Record Key: 63c02269-bb59-4586-9e91-3029060098f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR/X-ray HFD (HFD 200)
• Version Model Number: 113010-600
• 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	00857534006455 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [MR/X-ray HFD (HFD 200)]

• 00857534006028: MR/X-ray Head Fixation Device (HFD200), 113010-000
• 00857534006455: MR/X-ray Head Fixation Device (HFD 200)