Duns Number:333450844
Device Description: TeWa KB-Type 2030: coated acupuncture needles with Korean style, non-looped steel coil ha TeWa KB-Type 2030: coated acupuncture needles with Korean style, non-looped steel coil handle without guide tube Packaging: 1 needle per blister Size: Gauge 3(x 1.2") / 0.20 x 30 mm Color code: light blue Sales unit: 100 pieces
Catalog Number
A000804
Brand Name
TEWA
Version/Model Number
KB-Type 2030
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
K132896,K132896,K132896,K132896
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
98f16ab2-f861-4617-9519-03ea5259a041
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 30, 2017
Package DI Number
04251282514181
Quantity per Package
10
Contains DI Package
04251282514174
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
parcel
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |