Duns Number:017283879
Device Description: XprESS LoProfile 6x20mm ENT Dilation System
Catalog Number
LPLF-106
Brand Name
XprESS ENT Dilation System
Version/Model Number
MSB&LLF
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
LRC
Product Code Name
Instrument, Ent Manual Surgical
Public Device Record Key
aea41d2e-8adc-4737-ba6e-dc11278355ed
Public Version Date
September 21, 2020
Public Version Number
6
DI Record Publish Date
November 27, 2017
Package DI Number
10857326005014
Quantity per Package
1
Contains DI Package
00857326005017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Box
| 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 |