Duns Number:130213366
Device Description: Cleaning Brush - 890 L x 1.7mm OD x 25mm brush face
Catalog Number
-
Brand Name
Accu-Beam
Version/Model Number
91010-03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K910978,K910978
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
8d5c42d1-2cdd-416f-b62e-9828c6e75626
Public Version Date
July 06, 2022
Public Version Number
2
DI Record Publish Date
June 30, 2020
Package DI Number
B17791010033
Quantity per Package
10
Contains DI Package
B17791010030
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 | 134 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 303 |