Duns Number:176528040
Device Description: A non-sterile liquid in a spray container intended for localized application to the body s A non-sterile liquid in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling.
Catalog Number
3005
Brand Name
Green Guard Cold Spray
Version/Model Number
3005
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K033720,K033720
Product Code
MLY
Product Code Name
Refrigerant, Topical (Vapocoolant)
Public Device Record Key
2700f674-df5d-4b00-b43b-334d9fd1e112
Public Version Date
July 04, 2019
Public Version Number
1
DI Record Publish Date
June 26, 2019
Package DI Number
50347682030051
Quantity per Package
12
Contains DI Package
00347682030056
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |