Duns Number:007883297
Device Description: 25ga Illuminated MultiFlex™ Laser Probe, DORC Connector
Catalog Number
-
Brand Name
25ga Illuminated MultiFlex™ Laser Probe, DORC Connector
Version/Model Number
V6351-25JR
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)
-
FDA Premarket Submission
K121187,K121187
Product Code
MPA
Product Code Name
Endoilluminator
Public Device Record Key
2b9b5e9b-bf31-40d4-9d7f-dee75d0c9734
Public Version Date
January 15, 2021
Public Version Number
1
DI Record Publish Date
January 07, 2021
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1640 |
2 | A medical device with a moderate to high risk that requires special controls. | 288 |