Duns Number:007198742
Catalog Number
-
Brand Name
Everest BiCOAG MOLly Forceps 5mm/45cm
Version/Model Number
3345
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
K031078,K031078
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
74aab09f-1f99-452d-afda-2c3531d36fca
Public Version Date
April 23, 2019
Public Version Number
4
DI Record Publish Date
October 03, 2016
Package DI Number
00821925010918
Quantity per Package
5
Contains DI Package
00821925041578
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 899 |
2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
3 | A medical device with high risk that requires premarket approval | 9 |
U | Unclassified | 4 |