Duns Number:020198912
Device Description: Maryland Jaw Sealer/Divider
Catalog Number
LF1737
Brand Name
N/A
Version/Model Number
LF1737
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
K180499,K180499
Product Code
NUJ
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
Public Device Record Key
88933060-2f1c-4458-b0bc-109b3e2bdf7c
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 23, 2018
Package DI Number
57613327375812
Quantity per Package
6
Contains DI Package
07613327375817
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 |