Duns Number:071595540
Device Description: 4.5MM STERLING CYCLONE BUR, 6 EA
Catalog Number
H9118
Brand Name
NA
Version/Model Number
H9118
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
-
Product Code
GFF
Product Code Name
BUR, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
fce80654-bb61-4242-9758-161bc44cd1e7
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
20845854017330
Quantity per Package
6
Contains DI Package
10845854017333
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |