Duns Number:313517922
Device Description: DORO LUCENT® iMRI Headrest System MAQUET for GE consisting of:4003.3114003.0014003.0111 DORO LUCENT® iMRI Headrest System MAQUET for GE consisting of:4003.3114003.0014003.0111106.003
Catalog Number
-
Brand Name
DORO LUCENT® Headrest System
Version/Model Number
4003.400
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
K063494
Product Code
HBL
Product Code Name
Holder, Head, Neurosurgical (Skull Clamp)
Public Device Record Key
b80f6755-702c-4e99-816b-3d570ffb9313
Public Version Date
July 08, 2021
Public Version Number
5
DI Record Publish Date
December 15, 2016
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 | 72 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 477 |