Catalog Number
0475000000
Brand Name
Crossfire
Version/Model Number
0475000000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 26, 2021
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
K071859
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
f69a7f9f-52a0-4341-9eb3-0c4bec0e3626
Public Version Date
November 26, 2021
Public Version Number
5
DI Record Publish Date
September 23, 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 | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |