Duns Number:315304071
Device Description: BRONCHOSCOPE-TUBE ID 4.7MM by Nicolai-Mantel, OD 5.3mm, TL 300mm, without proximal light BRONCHOSCOPE-TUBE ID 4.7MM by Nicolai-Mantel, OD 5.3mm, TL 300mm, without proximal light connection, without distal viewing window, reusable
Catalog Number
82510.4530
Brand Name
NA
Version/Model Number
825104530
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
7eb0c8fd-a5da-4bd6-9dac-7cb29718a6bf
Public Version Date
August 19, 2022
Public Version Number
3
DI Record Publish Date
September 26, 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 |