Duns Number:600166524
Catalog Number
-
Brand Name
Stellar SapphireCool LG 8x15
Version/Model Number
Stellar SapphireCool LG 8x15
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170060
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
b72add89-852b-4e09-8024-f22d8fb7364d
Public Version Date
August 14, 2019
Public Version Number
1
DI Record Publish Date
August 06, 2019
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. | 361 |