Duns Number:832696038
Device Description: ROUND HARD DISSECTOR X-RAY DETECTABLE 3/8IN (9MM)
Catalog Number
23275-440
Brand Name
V. Mueller
Version/Model Number
23275-440
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
GDI
Product Code Name
DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
4c693a3e-ebfd-494f-8817-a3dfe8157218
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 12, 2018
Package DI Number
50885403067639
Quantity per Package
100
Contains DI Package
70885403067633
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 |