Duns Number:328420633
Device Description: Mini Tray empty with lid, for LOQTEQ VA Hinges
Catalog Number
-
Brand Name
LOQTEQ®
Version/Model Number
IC 6980-22
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
FSM
Product Code Name
TRAY, SURGICAL, INSTRUMENT
Public Device Record Key
1cb17812-71c3-4e04-8d45-afd192fbdaa8
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
February 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 | 738 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2701 |