Duns Number:187502109
Device Description: MICROFX OCD UNIVERSAL DRILL (PKG STERILE)
Catalog Number
234-200-200
Brand Name
MicroFX OCD
Version/Model Number
234-200-200
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
-
Product Code
HTW
Product Code Name
BIT, DRILL
Public Device Record Key
10a4ed88-5ddb-484d-ad6f-26aca81eb442
Public Version Date
July 23, 2020
Public Version Number
4
DI Record Publish Date
September 09, 2015
Package DI Number
37613327004091
Quantity per Package
5
Contains DI Package
07613327004090
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |