Duns Number:828730973
Device Description: 300 Watt Xenon Illuminator Used For Surgical Instrument Illumination.
Catalog Number
03-1300XSB
Brand Name
1300XSB
Version/Model Number
1300XSB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2026
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
K022384
Product Code
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
f61010eb-05d9-4be9-894a-9426a2b6d8af
Public Version Date
December 22, 2021
Public Version Number
5
DI Record Publish Date
December 01, 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. | 3 |