Duns Number:061228290
Device Description: Painless HBW PINE needles are made of surgical stainless steel with 20mm long spring style Painless HBW PINE needles are made of surgical stainless steel with 20mm long spring style metal handle without loop, Lightweight, affordable price with a high quality. Economical bulk packaging in 10 needles with one insertion tube. Box of 1000 needles, Size:36G x 15mm.
Catalog Number
KZ3605
Brand Name
HBW PINE
Version/Model Number
KZ Type No.36G 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
-
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
494e4d1e-e14f-4fec-8eef-5ddf4e7d0849
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 10, 2016
Package DI Number
20816073021569
Quantity per Package
30
Contains DI Package
00816073021565
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |