Duns Number:061228290
Device Description: HBW Sterile, disposable surgical stainless steel intradermal needles. 10 needles in foam p HBW Sterile, disposable surgical stainless steel intradermal needles. 10 needles in foam per sealed bulk package. Size: 0.12 x 5.0mm. Box of 100 needles
Catalog Number
23414
Brand Name
HBW INTRADERMAL NEEDLES
Version/Model Number
No.0.12mm x 5.0mm
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
e00378ae-188e-4ac4-8adc-9170039d9dda
Public Version Date
May 05, 2022
Public Version Number
1
DI Record Publish Date
April 27, 2022
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 |