Duns Number:197053028
Device Description: STANDARD RHINO TRAY CONTAINING A STANDARD WIRE MESH BASKET MEASURING 16" X 8.5" X 2.75", W STANDARD RHINO TRAY CONTAINING A STANDARD WIRE MESH BASKET MEASURING 16" X 8.5" X 2.75", WITH 4 TOTAL UNIVERSAL SCOPE & INSTRUMENT PROTECTION SYSTEM ASSEMBLIES AND A CUSTOMIZED CUT MAT
Catalog Number
-
Brand Name
SteriBest
Version/Model Number
CP4424-70-RT1
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
ac14d42c-8d11-446c-8c0a-3ed018e56296
Public Version Date
September 16, 2022
Public Version Number
2
DI Record Publish Date
February 23, 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 | 70 |