Duns Number:668367758
Device Description: TRAYS PLASTIC
Catalog Number
-
Brand Name
Premium Plus
Version/Model Number
653-20WT
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
Tray, Surgical, Instrument
Public Device Record Key
7e78a2c6-5315-4df8-a746-2d194159aedd
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
December 30, 2019
Package DI Number
D83865320WT8
Quantity per Package
2
Contains DI Package
D83865320WT6
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 166 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |