Duns Number:486741981
Device Description: Offset Reamer handles designed for required minimally invasive surgical approach of the hi Offset Reamer handles designed for required minimally invasive surgical approach of the hip joint. Various connections with reamer cutting tool and couplings with power tool (Big AO, Stryker-Zimmer/Hall and Harris) are available. It could be disassembled in 5 parts allowing the cleaning of the instrument. This is a reusable device.
Catalog Number
T18382
Brand Name
Carbon offset reamer handle AO with parking
Version/Model Number
T18382
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
d1627ed1-f073-49ef-8636-4dd76db0d228
Public Version Date
August 25, 2020
Public Version Number
1
DI Record Publish Date
August 17, 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 |