Duns Number:021717889
Device Description: Single-Use Bronchoscope
Catalog Number
M00542710
Brand Name
EXALT™ Model B
Version/Model Number
M00542710
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
EOQ
Product Code Name
Bronchoscope (flexible or rigid)
Public Device Record Key
5de06238-b0e3-4b1d-bb1c-e7faa5863264
Public Version Date
September 01, 2021
Public Version Number
1
DI Record Publish Date
August 24, 2021
Package DI Number
00191506007430
Quantity per Package
5
Contains DI Package
00191506007423
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |