Duns Number:061228290
Device Description: Painless HBW UNISHARP needles are made of surgical stainless steel with 25mm long spring s Painless HBW UNISHARP needles are made of surgical stainless steel with 25mm long spring style metal handle without loop, Lightweight, affordable price with a high quality. 10 needles with one insertion tube per sterile, individually packed a pouch. Needles are secured in guide tubes without tab for easy gauge identification. Box of 1000 needles, Size 34G x 50mm.
Catalog Number
T3420
Brand Name
HBW UNISHARP
Version/Model Number
T Type No.34G x 50m
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
1fc65046-265d-48d0-b86f-b4b14f6af80e
Public Version Date
September 17, 2019
Public Version Number
1
DI Record Publish Date
September 09, 2019
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |