Duns Number:527023772
Device Description: Single hand, plastic handle acupuncture needle, one needle with one tube in one blister,10 Single hand, plastic handle acupuncture needle, one needle with one tube in one blister,100pcs/box.
Catalog Number
-
Brand Name
YI SHEN BIAN QUE Acupuncture needle
Version/Model Number
0.25×40mm
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
K011242,K011242,K011242
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
acbcfd06-7050-4adc-b4e5-26ee1a343dc5
Public Version Date
March 25, 2019
Public Version Number
1
DI Record Publish Date
March 15, 2019
Package DI Number
26956418969522
Quantity per Package
100
Contains DI Package
16956418969525
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. | 2 |