Duns Number:049290364
Device Description: ELMED SLIM LINE BIPOLAR FORCEPS, BAYONET, 8'' (20CM), INSULATED ANGLED DOWN SHANK, 2-PIN ELMED SLIM LINE BIPOLAR FORCEPS, BAYONET, 8'' (20CM), INSULATED ANGLED DOWN SHANK, 2-PIN CONNECTOR, 0.5 MM MICRO-POLISHED GOLD PLATED TIP
Catalog Number
22-5100-08D
Brand Name
ELMED
Version/Model Number
22-5100-08D
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
a5618564-d351-42da-9f4b-f9f98c8aa8b6
Public Version Date
May 28, 2018
Public Version Number
1
DI Record Publish Date
April 25, 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 |