Duns Number:027680821
Device Description: Protects instrument trays from rips, holes and tears in sterilization wrap due to sharp tr Protects instrument trays from rips, holes and tears in sterilization wrap due to sharp tray corners, improper handling or heavy trays.
Catalog Number
-
Brand Name
Oxboro ™ Corner Protector
Version/Model Number
CP-80NS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 07, 2022
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
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
abb3d0e4-faaf-4aa7-8c68-70e5c448f01e
Public Version Date
October 20, 2022
Public Version Number
4
DI Record Publish Date
June 17, 2019
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 | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |