Duns Number:061228290
Device Description: Painless HBW needles in blister package made of surgical stainless steel, HBW needle provi Painless HBW needles in blister package made of surgical stainless steel, HBW needle provide practitioners with a high quality needle. The flexible plastic handle provides superior grip for the practitioner while the advanced manufacturing process provides a painless experience for the patient. Each easy-open plastic package contains 1 acupuncture needle. Box of 1 needle. 0.72 x 2mm.
Catalog Number
23470
Brand Name
HBW 7 STAR NEEDLES
Version/Model Number
No.0.72 X 2mm
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
3ea74ba9-7c58-446d-b590-6162d6402fbd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 27, 2016
Package DI Number
10816073022064
Quantity per Package
200
Contains DI Package
00816073022067
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 |