Duns Number:963856096
Device Description: Universal Compact Head Ring Post and Crossbar Kit
Catalog Number
UCHRP
Brand Name
CRW®
Version/Model Number
UCHRP
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
K160811,K944463
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
d02a13ee-3196-4f20-bca1-3232aa9c1e13
Public Version Date
October 26, 2022
Public Version Number
4
DI Record Publish Date
April 14, 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 | 1079 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2066 |