Duns Number:081277700
Device Description: AHT Bipolar Forceps Tips 10 1/2 Inches (26.7cm) Total Length 2mm Tip Diameter 5 1/2 Inches AHT Bipolar Forceps Tips 10 1/2 Inches (26.7cm) Total Length 2mm Tip Diameter 5 1/2 Inches (14cm) Working Length TIP STYLE Low Profile
Catalog Number
8155200S
Brand Name
CODMAN® ISOCOOL® AHT®
Version/Model Number
8155200S
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
Yes
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
K083895
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
b556c1da-0e03-48ec-916a-43a33e726c4e
Public Version Date
October 25, 2022
Public Version Number
5
DI Record Publish Date
April 01, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |