Duns Number:081305064
Device Description: TWEEZERS, TISSUE FORCEPS GERALD DELICATE 18cm T/C, WILL BE DISCONTINUED WHEN ALL REMAINING TWEEZERS, TISSUE FORCEPS GERALD DELICATE 18cm T/C, WILL BE DISCONTINUED WHEN ALL REMAINING STOCK IS DEPLETED, RECOMMEND 6525G
Catalog Number
N6525T
Brand Name
Power Dental U.S.A., Inc.
Version/Model Number
N6525T
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
EFL
Product Code Name
FORCEPS, DRESSING, DENTAL
Public Device Record Key
fc362982-c462-45c4-8c1a-47b2ca1e39c4
Public Version Date
July 21, 2021
Public Version Number
1
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 |