MR/X-ray HFD (HFD 200)

GUDID 00857534006028

MR/X-ray Head Fixation Device (HFD200), 113010-000

DEERFIELD IMAGING, INC.

Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp Skull clamp

• Primary Device ID: 00857534006028
• NIH Device Record Key: 5e0ebec0-ce0b-4c47-a871-97eed26229a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MR/X-ray HFD (HFD 200)
• Version Model Number: HFD 200
• 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	00857534006028 [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: 2016-09-05

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