Duns Number:711789789
Device Description: "MH-264 SD / FD HANDLE FOR REUSABLE SN AR"
Catalog Number
-
Brand Name
SD HANDLE
Version/Model Number
MH-264
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 15, 2022
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
-
Product Code
FAS
Product Code Name
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Public Device Record Key
2f7d5703-f94a-472c-bff6-feb466bdeb34
Public Version Date
August 16, 2022
Public Version Number
5
DI Record Publish Date
September 21, 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 | 117 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
| U | Unclassified | 52 |