Duns Number:061228290
Device Description: The ergonomically optimized and precisely centered handle ensures safe and convenient use. The ergonomically optimized and precisely centered handle ensures safe and convenient use. Measuring 2.0 x 20 mm, the handle is made of extremely lightweight and environmentally-friendly polypropylene plastic with Color-coded handles for easy gauge identification. Light Touch Insertion, the needle is easily released from its guide tube by gently pressing the needle away from its point of attachment on the tube, easy peel-open blister packaging. The needle is made of the highest quality surgical stainless steel. At the tip, it is filed to diamond sharpness and polished, making insertion particularly easy for the therapist and practically painless for the patient. Box of 100. Size: 30G x 50mm.
Catalog Number
HP3020
Brand Name
HBW HI.CHI
Version/Model Number
HP Type No.30G x 50mm
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
8bebc8ae-4b39-4cc8-938d-0d504acf7333
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 |