Duns Number:081305064
Device Description: X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 7 HAND INSTRUMENTS OR ANY INSTRUMENTS H X CASSETTES OPEN TYPE SURGICAL / UTILITY MORE THAN 7 HAND INSTRUMENTS OR ANY INSTRUMENTS HOLD. 205x93x35mm H
Catalog Number
7503P
Brand Name
Power Dental USA
Version/Model Number
7503P
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
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
3ded4883-94bd-4b51-8356-70d27842771c
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
January 08, 2022
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 |