Duns Number:527023772
Device Description: Stainless steel flat handle acupuncture needle, ten needles and one tube in one blister,10 Stainless steel flat handle acupuncture needle, ten needles and one tube in one blister,1000pcs/box.
Catalog Number
-
Brand Name
YI SHEN BIAN QUE Acupuncture needle
Version/Model Number
0.22×25mm
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
d0ee068c-e35b-43cb-9d34-387a93ffe456
Public Version Date
March 19, 2019
Public Version Number
1
DI Record Publish Date
March 11, 2019
Package DI Number
26956418969669
Quantity per Package
50
Contains DI Package
16956418969662
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 |