Duns Number:486741981
Device Description: Reamer handles designed for all required surgical approach of the hip joint. A dual connec Reamer handles designed for all required surgical approach of the hip joint. A dual connection with reamer cutting tool and 3 couplings with power tool (Big AO, Stryker-Zimmer/Hall and Hudson) are available.The handle could be disassembled allowing the cleaning of the instrument. This is a reusable device.
Catalog Number
T17781
Brand Name
Straight reamer handle Hudson dual coupling
Version/Model Number
T17781
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
9a8175df-0372-4c4a-a614-8fae3f4fb50e
Public Version Date
August 20, 2020
Public Version Number
1
DI Record Publish Date
August 12, 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 |