Duns Number:058701385
Device Description: Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905, blue Surgical Laser Fiber 272/300/380/450 micron, silicone, blue tefzel, NA 0.22, SMA 905, blue boot, single use, blue extension sleeve, Dome Tip, MF label
Catalog Number
-
Brand Name
MF-272/300-SBT-DT
Version/Model Number
MF-272/300Series
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
K124003
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
20a9e53a-8666-4821-8d34-1b3b52fe8f7d
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |