Duns Number:015409582
Device Description: 1 Each SUPER VIEW® Pack, Pivot Plus & 1 Each 40101 Microscope Head Cover Drape
Catalog Number
40229
Brand Name
Super View® Pack, Pivot Plus (40101+40227)
Version/Model Number
40229
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"
Yes
For Single-Use
Yes
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
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
0946f9c8-d5ab-4d94-96ca-083745cac348
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
November 24, 2020
Package DI Number
00852475007097
Quantity per Package
8
Contains DI Package
00852475007080
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 9 |
2 | A medical device with a moderate to high risk that requires special controls. | 8 |