Duns Number:327681359
Device Description: STORAGE TRAY FOR MIDDLE-EAR INSTRUMENTS WITH LID 3/4 CONTAINER, 405 X 252 X 45 MM NEW GENE STORAGE TRAY FOR MIDDLE-EAR INSTRUMENTS WITH LID 3/4 CONTAINER, 405 X 252 X 45 MM NEW GENERATION
Catalog Number
46.030.02
Brand Name
LAZIC
Version/Model Number
46.030.02
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
LRP
Product Code Name
Tray, Surgical
Public Device Record Key
896a2aec-f412-46d3-adbf-e1aadfde1984
Public Version Date
July 08, 2021
Public Version Number
2
DI Record Publish Date
January 15, 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 | 1084 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1125 |