Duns Number:023904428
Device Description: CAUTERY, HI-TEMP FINE
Catalog Number
-
Brand Name
Argent
Version/Model Number
231
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"
Yes
For Single-Use
Yes
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
HQP
Product Code Name
Unit, Cautery, Thermal, Battery-Powered
Public Device Record Key
d57a8fc5-1a95-4e0e-a7cb-df320ee284d9
Public Version Date
November 01, 2021
Public Version Number
4
DI Record Publish Date
December 09, 2016
Package DI Number
20612479209033
Quantity per Package
10
Contains DI Package
10612479209029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 870 |
2 | A medical device with a moderate to high risk that requires special controls. | 422 |
U | Unclassified | 44 |