Duns Number:486741981
Device Description: The straight guide is used to lead intramedullary reamer in its proper course into the med The straight guide is used to lead intramedullary reamer in its proper course into the medullary canal. The end piece permits to prevent and retain the intramedullary reamer in case of sliding along the guide. The length varies from 440 to 820 mm and the diameter from 2 to 3 mm. Two kind of head, permitting to maintain the intramedullary reamer, exist. This is a reusable device.
Catalog Number
T602
Brand Name
Straight guide Ø2 x 820 mm
Version/Model Number
T602
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
87bf49be-cbec-4efc-b511-286c63950bb4
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 |