Duns Number:049290364
Device Description: HAND ACTIVATED MONOPOLAR FORCEPS: JEWELERS, SMOOTH, CURVED TIP 3 1/2" (9CM) W/ATTACHED 10- HAND ACTIVATED MONOPOLAR FORCEPS: JEWELERS, SMOOTH, CURVED TIP 3 1/2" (9CM) W/ATTACHED 10-FT. CABLE, TWO PRONG PLUG FOR VALLEY LAB, CONMED, BOVIE, AND ELMED GENERATORS. INDICATE: LIST NO. 5XXX-XX +
Catalog Number
5226-03
Brand Name
ELMED
Version/Model Number
5226-03
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
a3d8d146-e652-4211-856f-dd9191933188
Public Version Date
July 05, 2018
Public Version Number
1
DI Record Publish Date
June 04, 2018
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 |