Duns Number:130213366
Device Description: Kit of 4 malleable fiber handpieces and sterilization tray. Included UDIs are:+B177AC90MMM Kit of 4 malleable fiber handpieces and sterilization tray. Included UDIs are:+B177AC90MMM0+B177AC140MMM0+B177AC240MMM0+B177AC300MMM0+B1771056521M0
Catalog Number
-
Brand Name
Accu-Beam
Version/Model Number
1056521M-Kit
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
K952006
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
7545b320-aa87-43be-bf3b-39f0f8e9fd7e
Public Version Date
September 08, 2021
Public Version Number
1
DI Record Publish Date
August 31, 2021
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 | 134 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 303 |