Duns Number:688432407
Catalog Number
-
Brand Name
IDryNeedle 0.35x75
Version/Model Number
DN161 0.35x75
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
4c142c2e-12dc-42e5-a2ce-941ecf997851
Public Version Date
March 05, 2020
Public Version Number
1
DI Record Publish Date
February 26, 2020
Package DI Number
28809407787073
Quantity per Package
10000
Contains DI Package
18809407787076
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTONBOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |