Duns Number:711789789
Catalog Number
-
Brand Name
IMH REMOTE/UCR COMMUNICATION CABLE FOR CV-170 2.5M
Version/Model Number
MAJ-2090
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 09, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063786
Product Code
FCX
Product Code Name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Public Device Record Key
1f1417d6-079b-4a02-8de2-838567a5c105
Public Version Date
August 10, 2022
Public Version Number
2
DI Record Publish Date
December 17, 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 | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |