Duns Number:529966489
Device Description: The specfication of electrodes is 50*50 and it is packed with color box (40 pieces) bold l The specfication of electrodes is 50*50 and it is packed with color box (40 pieces) bold line
Catalog Number
-
Brand Name
Lot Fancy
Version/Model Number
11A-1806-L
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
95fe8f60-ebba-4573-ace7-631c69779727
Public Version Date
July 08, 2020
Public Version Number
1
DI Record Publish Date
June 30, 2020
Package DI Number
16972011716519
Quantity per Package
2400
Contains DI Package
06972011716512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 123 |
U | Unclassified | 2 |