Duns Number:184763290
Catalog Number
28MC24130ST-I
Brand Name
Merit Maestro®
Version/Model Number
00884450315972
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OJV
Product Code Name
Single use instrument tray
Public Device Record Key
3d3532ad-aa54-4938-a363-12698d03dd81
Public Version Date
June 06, 2019
Public Version Number
1
DI Record Publish Date
May 29, 2019
Package DI Number
10884450315979
Quantity per Package
10
Contains DI Package
00884450315972
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 573 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8779 |