Duns Number:315304071
Device Description: TRACHEAL SCOPE-TUBE ID 11MM OD 13.2mm, TL 338mm, for use with the optical element 82510.1 TRACHEAL SCOPE-TUBE ID 11MM OD 13.2mm, TL 338mm, for use with the optical element 82510.1400 and head systems 825101100 and 825101200, without distal viewing window, graduated, reusable
Catalog Number
825210830
Brand Name
TEXAS
Version/Model Number
825210830
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
KTI
Product Code Name
BRONCHOSCOPE ACCESSORY
Public Device Record Key
5338a9fd-8d1f-43ac-850b-fb51b2dcaf16
Public Version Date
August 19, 2022
Public Version Number
4
DI Record Publish Date
September 28, 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 |