Duns Number:098308849
Device Description: TOOL MR8-T12MH45D MR8 12CM TL MH D 4.5MM
Catalog Number
-
Brand Name
MIDAS REX MR8
Version/Model Number
MR8-T12MH45D
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
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
K183515
Product Code
HBE
Product Code Name
DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
Public Device Record Key
76ed73f1-3c20-4edb-ab34-742e7c43ca20
Public Version Date
January 03, 2022
Public Version Number
1
DI Record Publish Date
December 24, 2021
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 | 450 |
2 | A medical device with a moderate to high risk that requires special controls. | 3534 |