Duns Number:239403863
Device Description: The forceps are for use during a variety of laparoscopic procedures for cutting, grasping, The forceps are for use during a variety of laparoscopic procedures for cutting, grasping, coagulation & transaction of vessels & tissue.
Catalog Number
PS3544ULT
Brand Name
Ultimate LapClinch with Ratchet
Version/Model Number
PS3544ULT
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
e6c6f217-3283-4087-9eb0-6092ee487b41
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
September 17, 2016
Package DI Number
35051223005477
Quantity per Package
5
Contains DI Package
05051223005476
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shelf box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |