Duns Number:081305064
Device Description: SCISSORS SUPER CUT SURGICAL CASTRO CVD 14 cm MICRO SURGEON LASER SHARP
Catalog Number
5929CS
Brand Name
Power Dental USA
Version/Model Number
5929CS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRW
Product Code Name
SCISSORS, GENERAL, SURGICAL
Public Device Record Key
a1a848d7-c4ce-4b0b-bed5-d6fccd2befe2
Public Version Date
September 23, 2022
Public Version Number
4
DI Record Publish Date
July 13, 2021
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 | 2768 |
2 | A medical device with a moderate to high risk that requires special controls. | 18 |