Duns Number:607846297
Device Description: CODMAN ISOCOOL AHT Bipolar Forceps Tips 10 1/2 Inches (26.7cm) Total Length 0.25mm Tip Dia CODMAN ISOCOOL AHT Bipolar Forceps Tips 10 1/2 Inches (26.7cm) Total Length 0.25mm Tip Diameter 5 1/2 Inches (14cm) Working Length TIP STYLE Low Profile
Catalog Number
8155025S
Brand Name
CODMAN ISOCOOL AHT
Version/Model Number
8155025S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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
6ec4a407-8e37-48ef-8e18-f1f2a8539e2b
Public Version Date
September 01, 2022
Public Version Number
5
DI Record Publish Date
June 30, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1054 |
| 3 | A medical device with high risk that requires premarket approval | 11 |