Duns Number:098308849
Device Description: TOOL MR8-LP07BA30 MR8 7CM LP BALL 3MM
Catalog Number
-
Brand Name
MIDAS REX MR8
Version/Model Number
MR8-LP07BA30
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
8445d962-6e47-4eff-b0db-40b5823af982
Public Version Date
April 22, 2022
Public Version Number
1
DI Record Publish Date
April 14, 2022
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 |