Duns Number:486741981
Device Description: The handle is proposed as accessory for the carbon offset reamer handles.This is a reusabl The handle is proposed as accessory for the carbon offset reamer handles.This is a reusable device.
Catalog Number
T18180
Brand Name
Handle for carbon offset reamer handle
Version/Model Number
T18180
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
6c7d5869-fbb2-40d2-b9f0-e92119009482
Public Version Date
September 03, 2020
Public Version Number
1
DI Record Publish Date
August 26, 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 |