Duns Number:312844095
Device Description: The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT envir The NORAS OR Head Holder LUCY is used for intra-operative imaging in the X-ray or CT environment. Together with the NORAS OR head coils 1.5T/3T the head holder LUCY is used for intra-operative MR imaging during neurosurgery on the open skull.
Catalog Number
119029
Brand Name
One-point Fixation with Force Indicator Adult LUCY
Version/Model Number
02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K211658
Product Code
HBL
Product Code Name
Holder, Head, Neurosurgical (Skull Clamp)
Public Device Record Key
864b8979-1a2a-4e27-8a91-3ff0d06ba39a
Public Version Date
May 26, 2022
Public Version Number
1
DI Record Publish Date
May 18, 2022
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 518 |