Duns Number:265741780
Device Description: Single use, blunt trocar for laparoscopic surgery
Catalog Number
5053H
Brand Name
NA
Version/Model Number
5053H
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"
Yes
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
86beffe0-bebb-4ace-988a-900197cdd05b
Public Version Date
January 09, 2020
Public Version Number
6
DI Record Publish Date
September 12, 2016
Package DI Number
03700393300455
Quantity per Package
25
Contains DI Package
03700393300462
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. | 839 |