Duns Number:690713813
Catalog Number
3151
Brand Name
OSADA ENAC OE-505
Version/Model Number
OE-505
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K844250
Product Code
ELC
Product Code Name
Scaler, ultrasonic
Public Device Record Key
151b3e05-7a98-41db-83d4-43a3bf1a7fb4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 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 |