Duns Number:081305064
Device Description: TITANIUM, MICRO SURGICAL CASTOVIEJO STR (6.3in=16cm) SERRATED
Catalog Number
N7722
Brand Name
Power Dental U.S.A., Inc.
Version/Model Number
N7722
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
b56c1713-8804-42e1-b9c3-5afe13c7e5ef
Public Version Date
June 28, 2021
Public Version Number
1
DI Record Publish Date
June 20, 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 |