Duns Number:690713813
Catalog Number
55741
Brand Name
SH42
Version/Model Number
SH42
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 07, 2017
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKX
Product Code Name
HANDPIECE, DIRECT DRIVE, AC-POWERED
Public Device Record Key
ce165480-c55d-4f8e-900a-4f80e470c157
Public Version Date
August 09, 2019
Public Version Number
4
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 | 56 |
2 | A medical device with a moderate to high risk that requires special controls. | 108 |
U | Unclassified | 8 |