Duns Number:315304071
Device Description: TELESCOPE 17° W 4.4MM H 2MM WL 314MM semi-rigid, with lateral ocular lens, with integrate TELESCOPE 17° W 4.4MM H 2MM WL 314MM semi-rigid, with lateral ocular lens, with integrated lens irrigation and protection sheath, for using with bronchoscope tubes 82520.0641, 85520.1441, TL 465mm, fiber image carrier
Catalog Number
82510.1400
Brand Name
TEXAS
Version/Model Number
825101400
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 02, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EOQ
Product Code Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
77e69841-812c-4662-bfc4-6fda81ee557f
Public Version Date
October 19, 2022
Public Version Number
3
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |