MR/X-ray HFD (HFD 210)

GUDID 00857534006004

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

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	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

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