Duns Number:185444825
Device Description: Megadyne Laparoscopic Tubing
Catalog Number
2390J
Brand Name
LAPAROSCOPIC TUBING
Version/Model Number
2390J
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
FCZ
Product Code Name
TUBE, SMOKE REMOVAL, ENDOSCOPIC
Public Device Record Key
26c28212-34b2-446d-846b-484ed4ebf677
Public Version Date
April 20, 2022
Public Version Number
8
DI Record Publish Date
August 11, 2020
Package DI Number
30614559104594
Quantity per Package
25
Contains DI Package
10614559104590
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 |