Duns Number:829838288
Device Description: Specimen Collector with Filter Element - Clamshell
Catalog Number
-
Brand Name
NICO Myriad
Version/Model Number
NN-9002
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)
-
FDA Premarket Submission
-
Product Code
FMH
Product Code Name
Container, Specimen, Sterile
Public Device Record Key
58c8e020-75c9-4ade-92e2-09491eb13324
Public Version Date
October 08, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
10816744029026
Quantity per Package
5
Contains DI Package
00816744029029
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 40 |
2 | A medical device with a moderate to high risk that requires special controls. | 62 |