Duns Number:058614483
Device Description: Bronchoscope Adapter for use with Pentax bronchoscopes
Catalog Number
-
Brand Name
ILLUMISITE
Version/Model Number
ILS-2200-PK
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"
Yes
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
K191394,K191394
Product Code
JAK
Product Code Name
System, x-ray, tomography, computed
Public Device Record Key
156934ef-3e83-4079-9e02-6770c7c98a48
Public Version Date
June 24, 2022
Public Version Number
3
DI Record Publish Date
October 12, 2019
Package DI Number
20884521723983
Quantity per Package
10
Contains DI Package
10884521723986
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |