Duns Number:318130267
Device Description: SonoTip II EBUS Flex with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for SonoTip II EBUS Flex with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax Endoscope, 22 Gauge Needle System, Round Nitinol Stylet, Needle ø 0.7 mm, outer ø 1.8 mm, plastic sheath
Catalog Number
GUS-22-18-022
Brand Name
SonoTip II EBUS Flex
Version/Model Number
GUS-22-18-022
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
-
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
0ddb388a-eb15-446c-b2b2-116cdfb47209
Public Version Date
July 12, 2019
Public Version Number
3
DI Record Publish Date
January 30, 2017
Package DI Number
04052838011105
Quantity per Package
5
Contains DI Package
04052838011112
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |