Duns Number:197053028
Device Description: INSTRUMENT TRAY ASSEMBLY 10 X 6 X .75 CONSISTS OF LID, SHALLOW BASE, MAT
Catalog Number
CP1038S
Brand Name
SteriBest
Version/Model Number
CP1038S
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
-
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
LRP
Product Code Name
Tray, Surgical
Public Device Record Key
4bbeab4e-5a87-42ad-9fa4-ec801df889d0
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
May 28, 2021
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 | 70 |