Duns Number:185444825
Device Description: Tube Adapter
Catalog Number
2151J
Brand Name
Megadyne
Version/Model Number
2151J
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
a330fe24-fa05-408b-b9f8-5eead5e0d85b
Public Version Date
October 03, 2022
Public Version Number
10
DI Record Publish Date
February 01, 2019
Package DI Number
30614559105737
Quantity per Package
100
Contains DI Package
10614559105733
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 219 |