Duns Number:832696038
Device Description: V. Mueller NEURO PATTIES X-RAY DETECTABLE 1/4 X 3IN (6.5 X 76MM)
Catalog Number
23275-330
Brand Name
V. Mueller
Version/Model Number
23275-330
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 15, 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"
Yes
For Single-Use
Yes
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
EFQ
Product Code Name
GAUZE/SPONGE, INTERNAL
Public Device Record Key
9f4ef36c-6c0f-487a-b1d3-f8493c245e5e
Public Version Date
March 04, 2022
Public Version Number
5
DI Record Publish Date
September 30, 2016
Package DI Number
50885403302853
Quantity per Package
20
Contains DI Package
70885403302857
Package Discontinue Date
February 15, 2021
Package Status
Not in Commercial Distribution
Package Type
Case
| 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 |