Duns Number:007883297
Device Description: Disposable KoAg Bipolar Forceps, 9", 1.5mm Straight Tips, Box of 5
Catalog Number
-
Brand Name
Disposable KoAg Bipolar Forceps, 9", 1.5mm Straight Tips, Box of 5
Version/Model Number
DNS9-15S
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
K123172,K123172
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
88d633aa-f43c-4577-8b1d-54efba921d23
Public Version Date
November 23, 2020
Public Version Number
1
DI Record Publish Date
November 15, 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 | 1640 |
2 | A medical device with a moderate to high risk that requires special controls. | 288 |