Duns Number:333450844
Device Description: TeWa 5CB-Type 1615 Speed Pak: coated acupuncture needles with copper-wire handle without TeWa 5CB-Type 1615 Speed Pak: coated acupuncture needles with copper-wire handle without guide tube Packaging: 5 needles per blister Size: Gauge 2(x 0.6") / 0.16 x 15 mm Color code: light brown Sales unit: 1,000 pieces
Catalog Number
A012181
Brand Name
TEWA
Version/Model Number
5CB-Type 1615 Speed Pak
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
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
c4413f22-0c7b-49f9-8b9e-73701c695503
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 30, 2017
Package DI Number
04251282514273
Quantity per Package
4
Contains DI Package
04251282514266
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 |