Duns Number:486711679
Device Description: PLATE BENDING PLIERS F/1.3MM LCKNG/1.5-2.0MM VAL PLATES-RT
Catalog Number
03130260
Brand Name
NA
Version/Model Number
03.130.260
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWW
Product Code Name
COUNTERSINK
Public Device Record Key
082857c6-55b4-4c97-aaf2-f09a87b218d2
Public Version Date
April 28, 2022
Public Version Number
3
DI Record Publish Date
October 12, 2017
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 | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |