Duns Number:078534357
Device Description: Surgical Laser Fiber 365/400/580 4m fiber, hard clad, blue tefzel, NA 0.22, Absorbing Dark Surgical Laser Fiber 365/400/580 4m fiber, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue extension sleeves with logo, EO sterile, Flat Tip, IML label
Catalog Number
-
Brand Name
HM-365A-L-FB
Version/Model Number
HM-365A-L-FB
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
Yes
FDA Premarket Submission
-
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
b928acaf-1867-42c1-a707-45487720e0fb
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
August 24, 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. | 19 |