Duns Number:080438702
Device Description: Reusable Bipolar Forceps Insulated, K-Yasargil, Bayonet 11.00"(27.9cm), 1.3mm Tip, Non-Sti Reusable Bipolar Forceps Insulated, K-Yasargil, Bayonet 11.00"(27.9cm), 1.3mm Tip, Non-Stick, Hidden Irrigation
Catalog Number
-
Brand Name
Sutter Medical Technologies USA, Inc.
Version/Model Number
SUT-528NS HR
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"
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
49a534b2-57e2-4c38-bc34-dcaf794bccc3
Public Version Date
April 21, 2020
Public Version Number
2
DI Record Publish Date
April 07, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |