Duns Number:020198912
Catalog Number
LF1212A
Brand Name
N/A
Version/Model Number
LF1212A
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
K220411,K220411
Product Code
NUJ
Product Code Name
Electrosurgical, cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed
Public Device Record Key
e3328eec-d22a-45be-9925-3bf6a1d9066f
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 10, 2022
Package DI Number
57613327565305
Quantity per Package
6
Contains DI Package
07613327565300
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 | 304 |
2 | A medical device with a moderate to high risk that requires special controls. | 1702 |
U | Unclassified | 12 |