Duns Number:315427286
Device Description: Ligature cutter, lingual
Catalog Number
-
Brand Name
N.A.
Version/Model Number
014-153-00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 16, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HXZ
Product Code Name
CUTTER, WIRE
Public Device Record Key
490d8383-12ea-4556-adc5-e7bf388c07c5
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
September 15, 2016
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. | 1745 |