Duns Number:158233937
Device Description: NUM is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for to NUM is a sterile topical anesthetic spray – vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries.
Catalog Number
-
Brand Name
NUM Vapocoolant
Version/Model Number
NS01B
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
-
Product Code
MLY
Product Code Name
Vapocoolant Device
Public Device Record Key
3e5d8640-f76f-418e-8332-bc31513b3772
Public Version Date
June 14, 2021
Public Version Number
1
DI Record Publish Date
June 04, 2021
Package DI Number
10850025535998
Quantity per Package
2
Contains DI Package
00850025535991
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-