Duns Number:313517922
Device Description: DORO LUCENT® iXI Parallelogram Adaptor MAQUET
Catalog Number
-
Brand Name
DORO LUCENT® iXI Parallelogramm Adapter Maquet
Version/Model Number
4003.511
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
-
Product Code
HBL
Product Code Name
Holder, Head, Neurosurgical (Skull Clamp)
Public Device Record Key
f7840ce4-de94-44b1-8d86-1e3966838da9
Public Version Date
July 08, 2021
Public Version Number
4
DI Record Publish Date
January 25, 2019
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 |