Duns Number:557793906
Catalog Number
-
Brand Name
Hansol Medical Co.
Version/Model Number
0.35mm x 15mm
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
K090910,K090910
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
0eba8bb1-76fa-459d-8109-e8dd39953093
Public Version Date
May 17, 2021
Public Version Number
2
DI Record Publish Date
February 11, 2019
Package DI Number
18809118710578
Quantity per Package
10
Contains DI Package
08809118710571
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 15 |
2 | A medical device with a moderate to high risk that requires special controls. | 20 |