Duns Number:015903922
Device Description: Fiberoptic Light Cable, 7.5', Olympus to ACMI
Catalog Number
MLGO4X7AC
Brand Name
mytaMed
Version/Model Number
MLGO4X7AC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
EQH
Product Code Name
Source, Carrier, Fiberoptic Light
Public Device Record Key
bb2420f0-2624-4f40-bf85-da63a9604bda
Public Version Date
February 17, 2021
Public Version Number
1
DI Record Publish Date
February 09, 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 | 861 |
2 | A medical device with a moderate to high risk that requires special controls. | 21 |