Duns Number:046355210
Device Description: Rubber Bipolar Forceps Cord 12', Steam Sterilize Fits all Standard Bipolar Forceps
Catalog Number
-
Brand Name
Weck
Version/Model Number
394237
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 06, 2018
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"
Yes
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
K831236
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
d87d28aa-e762-4c59-a6f6-f5006ac08213
Public Version Date
November 07, 2018
Public Version Number
4
DI Record Publish Date
July 17, 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 | 60 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1505 |
| U | Unclassified | 2 |