Duns Number:025460908
Device Description: LIGASURE SMALL JAW FOR FORCETRIAD ONLY
Catalog Number
LF1212AR
Brand Name
Medline
Version/Model Number
LF1212AR
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
K162751,K162751
Product Code
NUJ
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
Public Device Record Key
5c7093f4-d4e1-44bf-80e0-cffb9eb6cf2a
Public Version Date
September 27, 2021
Public Version Number
2
DI Record Publish Date
October 30, 2020
Package DI Number
20888277664170
Quantity per Package
6
Contains DI Package
10888277664173
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |