Duns Number:071595540
Device Description: 4.0MM OR 4.5MM BUR SHEATH TO MAKE UNHOODED BUR
Catalog Number
H9002
Brand Name
NA
Version/Model Number
H9002
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
84858bd2-7640-42bd-9347-9e3c6d0e37ad
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
October 14, 2021
Package DI Number
20845854029609
Quantity per Package
1
Contains DI Package
10845854029602
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 |