Duns Number:315018218
Device Description: Bipolar Forceps, straight, 10", (255 mm), working length: 5 1/4", (135 mm), offset shanks, Bipolar Forceps, straight, 10", (255 mm), working length: 5 1/4", (135 mm), offset shanks, smooth, spring type, flat handle, insulated, width: 1 mm, black, non-sterile - autoclavable
Catalog Number
GK828R
Brand Name
AESCULAP
Version/Model Number
GK828R
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
cfb47d8c-29bd-4e46-b0ab-9aeaae5631b0
Public Version Date
April 27, 2021
Public Version Number
4
DI Record Publish Date
September 23, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |