Duns Number:333450844
Device Description: asia-med Apex Steel: uncoated semi-permanent acupuncture needles with applicator and magne asia-med Apex Steel: uncoated semi-permanent acupuncture needles with applicator and magnet. Incl. 100 plasters Packaging: 1 needle per blister Size (needle): 1,3 x 3.2 mm Sales unit: 100 pieces
Catalog Number
A000557
Brand Name
ASIA MED
Version/Model Number
Apex
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
K011808,K011808,K011808
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
ab611fc1-3bb7-4892-8760-4e1725c687c5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 30, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |