Duns Number:832696038
Device Description: V. Mueller OPTICARE COMBINATION ARTHROSCOPE TRAY 10.5X6.25X1.36" (267X159X34MM)
Catalog Number
GP3-7110
Brand Name
V. Mueller
Version/Model Number
GP3-7110
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 02, 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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
23ad2a48-dc51-489d-af58-ba8fb9b757aa
Public Version Date
June 24, 2022
Public Version Number
6
DI Record Publish Date
March 19, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |