Duns Number:627879687
Device Description: The Vortex Spray Kit is for use as a cryosurgical tool to ablate benign lesions (e.g., Bar The Vortex Spray Kit is for use as a cryosurgical tool to ablate benign lesions (e.g., Barrett's Esophagus with high grade and/or low grade dysplasia) in the upper gastrointestinal tract using active venting.
Catalog Number
2000360
Brand Name
truFreeze
Version/Model Number
2000360
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
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
K201183,K201183
Product Code
GEH
Product Code Name
UNIT, CRYOSURGICAL, ACCESSORIES
Public Device Record Key
e7befef8-ea87-4884-9a3e-c2de2b5b3652
Public Version Date
December 27, 2021
Public Version Number
1
DI Record Publish Date
December 17, 2021
Package DI Number
10724995199231
Quantity per Package
4
Contains DI Package
00724995199234
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |