Duns Number:688432407
Catalog Number
-
Brand Name
IDryNeedle 0.30x40
Version/Model Number
DN150 0.30x40
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
b65d5916-ebdf-4c0b-9a75-85042b4f72e3
Public Version Date
May 24, 2021
Public Version Number
2
DI Record Publish Date
January 15, 2020
Package DI Number
28809407787042
Quantity per Package
1000
Contains DI Package
18809407787045
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
OUTBOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |