Duns Number:040729840
Device Description: INSULATED METAL HANDLE ANGLED ROTATING HEAD FOR 3 MILLIMETER,5 MILLIMETER,10 MILLIMETER TU INSULATED METAL HANDLE ANGLED ROTATING HEAD FOR 3 MILLIMETER,5 MILLIMETER,10 MILLIMETER TUBE SHAFT
Catalog Number
-
Brand Name
INSULATED METAL HANDLE
Version/Model Number
2901-060
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"
Yes
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
K102921
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
b42d1d5d-d53e-409f-bc71-2d12ef0b3f95
Public Version Date
March 03, 2020
Public Version Number
1
DI Record Publish Date
February 24, 2020
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 | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |