Duns Number:103169095
Device Description: OASIS BIODEGRADABLE SCOPE TRANSPORT TRAY WITH REVERSIBLE LID FOR SMALL DIAMTER SCOPES AND OASIS BIODEGRADABLE SCOPE TRANSPORT TRAY WITH REVERSIBLE LID FOR SMALL DIAMTER SCOPES AND SMALLER INSTRUMENTS, 10" x 16" - 30 TRAYS & 30 LIDS
Catalog Number
-
Brand Name
Oasis Biodegradable Scope Transport Tray with Reversible lid
Version/Model Number
OT1016
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
Yes
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
PXV
Product Code Name
General Purpose Instrument Tray
Public Device Record Key
ecf522bc-b33d-4ad2-bdf4-f41eda1c8d0b
Public Version Date
March 07, 2022
Public Version Number
2
DI Record Publish Date
February 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 | 146 |