Duns Number:832696038
Device Description: V. Mueller UNIVERSAL 8 X 17 SHALLOW (FULL SIZE CASE) WITH MAT 8.25X17.3X.62" (210X439X16MM V. Mueller UNIVERSAL 8 X 17 SHALLOW (FULL SIZE CASE) WITH MAT 8.25X17.3X.62" (210X439X16MM)
Catalog Number
GP6-8700
Brand Name
V. Mueller
Version/Model Number
GP6-8700
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 12, 2021
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)
Yes
Over the Counter (OTC)
-
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
8c3989a7-ba4e-454a-a70c-ab95acfca893
Public Version Date
March 07, 2022
Public Version Number
5
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 |