Head Fixation Device HFD100 - Head Fixation Device HFD100 , 113803-600 - DEERFIELD IMAGING, INC.

Duns Number:079990922

Device Description: Head Fixation Device HFD100 , 113803-600

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More Product Details

Catalog Number

-

Brand Name

Head Fixation Device HFD100

Version/Model Number

HFD100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K103493

Product Code Details

Product Code

HBL

Product Code Name

Holder, Head, Neurosurgical (Skull Clamp)

Device Record Status

Public Device Record Key

f187eab3-8b72-4675-9411-7dae5e3f307d

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

February 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEERFIELD IMAGING, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 19
2 A medical device with a moderate to high risk that requires special controls. 39