Duns Number:315304071
Device Description: SCREW CAP Ø 5MM SL 41MM for use with grasping forceps inserts 8393704, 8393705, 8393714, SCREW CAP Ø 5MM SL 41MM for use with grasping forceps inserts 8393704, 8393705, 8393714, 8393724, 8393725, 8393726, reusable
Catalog Number
8393.976
Brand Name
NA
Version/Model Number
8393976
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
-
Prescription Use (Rx)
-
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
84e1650f-e26f-48e4-b1a6-21d90c3fe17f
Public Version Date
September 21, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |