Duns Number:832696038
Device Description: Neuro Patties X-Ray Detectable 1/2x1in (13x25mm)
Catalog Number
23275-520
Brand Name
V. Mueller
Version/Model Number
23275-520
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"
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
30a754d1-7246-480f-bea1-86661708c6d8
Public Version Date
March 15, 2021
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
50885403067653
Quantity per Package
20
Contains DI Package
70885403067657
Package Discontinue Date
-
Package Status
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 |