Duns Number:080300717
Device Description: Wire Brush, 9.50mm, FH7, Sterile Packaged
Catalog Number
FHTPWB4
Brand Name
NA
Version/Model Number
FHTPWB4
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
LXH
Product Code Name
Orthopedic Manual Surgical Instrument
Public Device Record Key
420756a4-ee34-41a7-95ed-ee41f112d27e
Public Version Date
May 13, 2022
Public Version Number
3
DI Record Publish Date
August 17, 2021
Package DI Number
00810045534732
Quantity per Package
10
Contains DI Package
00810004729124
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 787 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1255 |