Duns Number:079990922
Device Description: Head Fixation Device HFD100 , 113803-600
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
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
HBL
Product Code Name
Holder, Head, Neurosurgical (Skull Clamp)
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |