Duns Number:007198742
Catalog Number
-
Brand Name
STAPES H'PC F/DIEGO (NO EEPROM) REFURBISHED
Version/Model Number
70338032R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 28, 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K992994
Product Code
ERL
Product Code Name
DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
Public Device Record Key
e726378f-3389-4a38-9934-17e8be4ac7af
Public Version Date
September 16, 2022
Public Version Number
4
DI Record Publish Date
October 06, 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 | 899 |
2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
3 | A medical device with high risk that requires premarket approval | 9 |
U | Unclassified | 4 |