Duns Number:071465330
Device Description: Ligature Tying (Wing Tip Plier)
Catalog Number
-
Brand Name
Orthopli
Version/Model Number
O10-W
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"
-
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
JEX
Product Code Name
Plier, Orthodontic
Public Device Record Key
d9aa694a-faff-49f0-b6d1-7075e197b039
Public Version Date
October 09, 2019
Public Version Number
1
DI Record Publish Date
October 01, 2019
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 | 20 |
2 | A medical device with a moderate to high risk that requires special controls. | 10 |