Duns Number:015227072
Device Description: This hand - held, orthopedic, manual, surgical instrument handle is designed to connect to This hand - held, orthopedic, manual, surgical instrument handle is designed to connect to shaft type instruments, such as awls, taps, screw drivers and similar instruments used by a surgeon to prepare fasteners or constructs for installation, driving or adjusting fasteners or to perform manipulations during surgery. This is a reusable device.
Catalog Number
G107212
Brand Name
Gauthier Biomedical
Version/Model Number
G107212
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
63ca1213-78e7-42cc-98d0-86fdca5b3af8
Public Version Date
May 11, 2022
Public Version Number
2
DI Record Publish Date
August 07, 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 | 39 |