Duns Number:529966489
Device Description: The specfication of electrodes is150x100 (A small bag of 4 pcs, a medium box of 100pcs)
Catalog Number
-
Brand Name
Lot Fancy
Version/Model Number
150*100
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
f5e27178-c645-442a-83f1-01f3fa2345fe
Public Version Date
June 01, 2021
Public Version Number
1
DI Record Publish Date
May 24, 2021
Package DI Number
16972011716601
Quantity per Package
400
Contains DI Package
06972011716604
Package Discontinue Date
May 24, 2021
Package Status
Not 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 |