Duns Number:315304071
Device Description: BRONCHOSCOPE-TUBE ID 8.5MM model Hemer, OD 9.5mm, TL 430mm, with proximal illumination an BRONCHOSCOPE-TUBE ID 8.5MM model Hemer, OD 9.5mm, TL 430mm, with proximal illumination and sampling channel, without distal viewing window, graduated, reusable
Catalog Number
8214.084
Brand Name
NA
Version/Model Number
8214084
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
-
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
dc42a1e1-5e60-4180-97db-5a15859539ee
Public Version Date
April 26, 2021
Public Version Number
5
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 |