Duns Number:832696038
Device Description: ROSEN FENESTROMETER GRADUATED IN MILLIMETERS, TO 4MM MAXIMUM OVERALL LENGTH 6-3/8" (16.2CM ROSEN FENESTROMETER GRADUATED IN MILLIMETERS, TO 4MM MAXIMUM OVERALL LENGTH 6-3/8" (16.2CM)
Catalog Number
AU11395
Brand Name
V. Mueller
Version/Model Number
AU11395
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"
-
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
JYJ
Product Code Name
GAUGE, MEASURING
Public Device Record Key
fa9ef2d1-988d-41c5-a9e7-db1d97387be4
Public Version Date
November 22, 2018
Public Version Number
2
DI Record Publish Date
July 13, 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 |