Duns Number:061228290
Device Description: HBW HIKARI acupuncture needle is made from the highest quality surgical stainless steel Ja HBW HIKARI acupuncture needle is made from the highest quality surgical stainless steel Japanese style PIPE type acupuncture needles with 20 mm long metal handle. Features quick-release guide tube without holding tab. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100, Size 32G x 40mm.
Catalog Number
OP3215
Brand Name
HBW HIKARI
Version/Model Number
OP Type No.32G x 40mm
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
fee2ee10-2aad-477c-8e23-5445f367c6cd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 10, 2016
Package DI Number
20816073021910
Quantity per Package
10
Contains DI Package
00816073021916
Package Discontinue Date
-
Package Status
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 |