Catalog Number

LPLF-206

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

2c44dfb7-877d-4958-9644-21dd3e9cea58

Public Version Date

September 21, 2020

Public Version Number

6

DI Record Publish Date

November 27, 2017

Package DI Number

10857326005045

Quantity per Package

1

Contains DI Package

00857326005048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box