Duns Number:529966489
Device Description: SHUNLI Plastic handle acupuncture needles are sterile disposable, The needle length is 50m SHUNLI Plastic handle acupuncture needles are sterile disposable, The needle length is 50mm length , One needle with one insertion tube per sterile, individually sealed blisterpackage. 200 needles per box.
Catalog Number
-
Brand Name
SHUNLI
Version/Model Number
0.30*50
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
9d9e0077-f94c-4f51-8fe2-aeb070ff9d6a
Public Version Date
January 07, 2019
Public Version Number
1
DI Record Publish Date
December 05, 2018
Package DI Number
20810011251285
Quantity per Package
8
Contains DI Package
10810011251288
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. | 123 |
| U | Unclassified | 2 |