Duns Number:080254074
Device Description: ELEOS™ INSTRUMENTATION TRAY, RESURFACING STEM TRIALS, TRAY 5 - COMPLETE
Catalog Number
001-03-10005
Brand Name
ELEOS™
Version/Model Number
001-03-10005
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
8d4d832d-6589-4f88-af31-14e0c46b3724
Public Version Date
September 16, 2022
Public Version Number
8
DI Record Publish Date
March 20, 2017
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 |