Duns Number:807703996
Device Description: 2" x 3.5" Pediatric Butterfly w/ Snap
Catalog Number
-
Brand Name
Freedom Stim
Version/Model Number
NC89800-P
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070807,K070807,K070807
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
388cc613-fef3-4c88-b6b2-f6fb91cae10a
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
January 19, 2017
Package DI Number
00677346320774
Quantity per Package
12
Contains DI Package
00677346310751
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |