Duns Number:185444825
Device Description: Mega Soft Compatibility Cable 4.4 m (14'-5")
Catalog Number
M2K09
Brand Name
Mega Soft
Version/Model Number
M2K09
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
-
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
K080741,K133726,K080741,K133726
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
429e7d94-9a0c-4608-a54b-168db070285b
Public Version Date
June 11, 2021
Public Version Number
9
DI Record Publish Date
September 05, 2018
Package DI Number
30614559105256
Quantity per Package
40
Contains DI Package
10614559105252
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 219 |