Duns Number:073436164
Catalog Number
-
Brand Name
IMCO-Micro-Scientific
Version/Model Number
G28-IMC
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
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
52219eaa-3bad-48dc-a9e7-8baf9a413261
Public Version Date
June 05, 2018
Public Version Number
3
DI Record Publish Date
July 25, 2016
Package DI Number
10815842023639
Quantity per Package
4
Contains DI Package
00815842023632
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 42 |