Duns Number:059066475
Device Description: 7.3/2.90mm Cannulated Drill Bit, Coated, Large Quick Connect, 300mm length
Catalog Number
RNL-310-495-C
Brand Name
Renovo Life, LLC
Version/Model Number
RNL-310-495-C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWE
Product Code Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Public Device Record Key
ea5e0a58-1ad4-442c-8c16-a95e53848322
Public Version Date
November 22, 2018
Public Version Number
3
DI Record Publish Date
November 14, 2017
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 | 36 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |