Duns Number:832696038
Device Description: UNIVERSITY OF IOWA COTTON APPLICATOR FLAT, PARTIALLY SERRATED TIP OVERALL LENGTH 6" (15.2C UNIVERSITY OF IOWA COTTON APPLICATOR FLAT, PARTIALLY SERRATED TIP OVERALL LENGTH 6" (15.2CM)
Catalog Number
RH240
Brand Name
V. Mueller
Version/Model Number
RH240
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 23, 2019
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
KXF
Product Code Name
APPLICATOR, ABSORBENT TIPPED, NON-STERILE
Public Device Record Key
2328e5ab-1777-41ab-aed5-ada43f55930c
Public Version Date
January 10, 2020
Public Version Number
3
DI Record Publish Date
September 10, 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 |