Duns Number:832696038
Device Description: V. Mueller STERILE PATTIES COTTON 3/4X3/4IN 200/BX
Catalog Number
NL9052
Brand Name
V. Mueller
Version/Model Number
NL9052
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"
-
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
GDY
Product Code Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Public Device Record Key
aaa60bd0-e909-42eb-9701-d50b9064ea92
Public Version Date
March 07, 2022
Public Version Number
2
DI Record Publish Date
August 30, 2018
Package DI Number
70885403128488
Quantity per Package
10
Contains DI Package
10885403128486
Package Discontinue Date
February 15, 2021
Package Status
Not in Commercial Distribution
Package Type
Pack
| 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 |