Duns Number:080254074
Device Description: ELEOS Reduced Resection Collar Reamer Trial, 17mm
Catalog Number
SB-170RT-03N
Brand Name
ELEOS Limb Salvage System With BioGrip
Version/Model Number
SB-170RT-03N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
94e3a186-37f1-411e-aa2c-d15e8c8c3a98
Public Version Date
August 03, 2021
Public Version Number
1
DI Record Publish Date
July 26, 2021
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 | 378 |
2 | A medical device with a moderate to high risk that requires special controls. | 231 |
3 | A medical device with high risk that requires premarket approval | 4 |