Duns Number:389567538
Device Description: Medilas D30 1064 Diode Laser, SMA
Catalog Number
K2012015
Brand Name
Dornier MedTech
Version/Model Number
Medilas D30 1064 (SMA)
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080959
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
e958e15f-29ad-45aa-97b6-1b2bd9371ab2
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 12, 2018
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. | 28 |