Duns Number:313088331
Device Description: LLIF instrument tray
Catalog Number
-
Brand Name
EIT LLIF Tray
Version/Model Number
LEC00100
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
OJH
Product Code Name
Orthopedic Tray
Public Device Record Key
1053118f-c612-4d50-988b-7495b0a5c0a4
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
November 28, 2018
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 | 234 |
2 | A medical device with a moderate to high risk that requires special controls. | 1726 |