Duns Number:049290364
Device Description: 5MM, 45CM, CLEAR FLUSH, "MCKEARNAN" STYLE FUNDUS GRASPER, RADEL INSULATION, RIGID, ONE PIE 5MM, 45CM, CLEAR FLUSH, "MCKEARNAN" STYLE FUNDUS GRASPER, RADEL INSULATION, RIGID, ONE PIECE
Catalog Number
5-0545-126A
Brand Name
ELMED
Version/Model Number
5-0545-126A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181173
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
681f0f94-9f16-4499-b520-145a7e34ded6
Public Version Date
October 14, 2022
Public Version Number
1
DI Record Publish Date
October 06, 2022
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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4068 |