Duns Number:013486803
Device Description: Chandelier Fiber Probe with Adjustable Ring, 25Ga. with 19Ga. Needle Type Connector
Catalog Number
5316
Brand Name
NA
Version/Model Number
NA
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K982462,K982462
Product Code
FFS
Product Code Name
Image, Illumination, Fiberoptic, For Endoscope
Public Device Record Key
45b4f272-aefa-46d3-ab39-c2cf1df20b04
Public Version Date
May 07, 2019
Public Version Number
4
DI Record Publish Date
January 17, 2018
Package DI Number
30818255011167
Quantity per Package
5
Contains DI Package
10818255011163
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |