Duns Number:074912476
Device Description: Instrument and Device Tray. Includes parts NN-01-CD-01 Caddy, NN-01-CD-02 Caddy Lid, NN-01
Catalog Number
-
Brand Name
Tray
Version/Model Number
NN-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
OJG
Product Code Name
Neurological Tray
Public Device Record Key
3505a829-e5ca-460d-bb40-fd39ea15abc4
Public Version Date
August 19, 2022
Public Version Number
2
DI Record Publish Date
June 21, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |