Duns Number:058701385
Device Description: Surgical Laser Fiber 365/400/470/580, silicone, blue tefzel, NA 0.22, damage resistant SMA Surgical Laser Fiber 365/400/470/580, silicone, blue tefzel, NA 0.22, damage resistant SMA905, single use, EO sterile, gold extension sleeve, Dome Tip, MF label
Catalog Number
-
Brand Name
MF-365/400-DT
Version/Model Number
MF-365/400-DT
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
8253b918-4ae7-4d62-94ce-37c30c4584f7
Public Version Date
April 07, 2021
Public Version Number
5
DI Record Publish Date
September 07, 2016
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 |