Duns Number:061228290
Device Description: Painless HBW PINE needles are made of surgical stainless steel with 25mm long spring style Painless HBW PINE needles are made of surgical stainless steel with 25mm long spring style metal handle without loop, Lightweight, affordable price with a high quality. One needle with one insertion tube per sterile, individually sealed blister package. Needles are secured in guide tubes with colored holding tab for easy gauge identification. Box of 200 needles, Size:40G x 15mm.
Catalog Number
KA4005
Brand Name
HBW PINE
Version/Model Number
KA Type No.40G x 15mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 15, 2019
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
1d7e152d-28ea-4914-96bc-6f14186a161c
Public Version Date
April 23, 2019
Public Version Number
1
DI Record Publish Date
April 15, 2019
Package DI Number
10816073022613
Quantity per Package
50
Contains DI Package
00816073022616
Package Discontinue Date
April 15, 2019
Package Status
Not in Commercial Distribution
Package Type
case
| 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 |