Duns Number:832696038
Device Description: MCCABE MEASURING INSTRUMENT SLIGHTLY CURVED ROUND SHAFT W/CALIBRATIONS AT 3, 4 & 5MM OVERA MCCABE MEASURING INSTRUMENT SLIGHTLY CURVED ROUND SHAFT W/CALIBRATIONS AT 3, 4 & 5MM OVERALL LENGTH 6-1/8"(15.6CM)
Catalog Number
AU12830
Brand Name
V. Mueller
Version/Model Number
AU12830
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
00eac56c-0ab7-4d8f-8fa8-5bc89bd81ecc
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 |