Duns Number:486741981
Device Description: A hand-held re-usable surgical device designed to simultaneously direct the placement and A hand-held re-usable surgical device designed to simultaneously direct the placement and angle of the drill hole and protect the surrounding tissue. It is cannulated to accept a dedicated drill bit size and has a serrated distal end to allow firm placement on the bone. The variable angle is from 25° to 65°.
Catalog Number
T5011
Brand Name
Adjustable drill guide, Ø3.2 mm, 25° to 65°
Version/Model Number
T5011
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
-
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
FZX
Product Code Name
Guide, Surgical, Instrument
Public Device Record Key
9e1cb2df-30a4-4e1c-a390-4797d5d3e5f4
Public Version Date
August 26, 2020
Public Version Number
1
DI Record Publish Date
August 18, 2020
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 | 299 |