Duns Number:688432407
Catalog Number
-
Brand Name
IDryNeedle Bulk 500 0.30x60
Version/Model Number
DN151 0.30x60
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
e66ffb3a-77a7-40a6-9611-56f8ef639f71
Public Version Date
May 27, 2021
Public Version Number
1
DI Record Publish Date
May 19, 2021
Package DI Number
28809407788612
Quantity per Package
5000
Contains DI Package
18809407788615
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 |