Duns Number:963856096
Device Description: 8-32X1/2 SS SOCKET CAP SCREW
Catalog Number
-
Brand Name
CRW®
Version/Model Number
SHDWHS0816OC
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
K944463
Product Code
HAW
Product Code Name
Neurological stereotaxic Instrument
Public Device Record Key
d56a1b40-5baf-458b-a679-ced001b1e5e8
Public Version Date
September 16, 2019
Public Version Number
3
DI Record Publish Date
September 29, 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 | 1079 |
2 | A medical device with a moderate to high risk that requires special controls. | 2066 |