Duns Number:078797666
Device Description: CryoDose TA Topical Anesthetic Mist Spray 115 mL
Catalog Number
1802
Brand Name
CryoDose TA
Version/Model Number
1802
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
-
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
MLY
Product Code Name
REFRIGERANT, TOPICAL (VAPOCOOLANT)
Public Device Record Key
f1076dad-5c12-48ac-a67c-0e90b061614f
Public Version Date
July 15, 2021
Public Version Number
3
DI Record Publish Date
March 06, 2017
Package DI Number
10856331006146
Quantity per Package
12
Contains DI Package
00856331006149
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |