Duns Number:017283879
Device Description: XprESS Pro 6x18mm ENT Dilation System
Catalog Number
JD-106
Brand Name
XprESS ENT Dilation System
Version/Model Number
MSB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 18, 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
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
LRC
Product Code Name
Instrument, Ent Manual Surgical
Public Device Record Key
0ea671b6-3fc7-4af5-a024-b36060698ed7
Public Version Date
September 08, 2021
Public Version Number
7
DI Record Publish Date
November 27, 2017
Package DI Number
10857326005052
Quantity per Package
1
Contains DI Package
00857326005055
Package Discontinue Date
September 18, 2020
Package Status
Not in Commercial Distribution
Package Type
Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |