Duns Number:529966489
Device Description: SHUNLI Plastic handle acupuncture needles are sterile disposable. The needle length is 15m SHUNLI Plastic handle acupuncture needles are sterile disposable. The needle length is 15mm length. One needle with one insertion tube per sterile, individually sealed blister package. Needles are secured in guide tubes with plastic holding tabs. 200 needles per box.
Catalog Number
-
Brand Name
SHUNLI
Version/Model Number
0.20*15
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)
Yes
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
0e847612-31e9-4bbd-b4f2-406a9e1731e9
Public Version Date
September 15, 2021
Public Version Number
4
DI Record Publish Date
October 25, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |