Catalog Number

SEID

Brand Name

ACCLARENT SE INFLATION DEVICE

Version/Model Number

SEID

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

K150172,K150172

Product Code

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Public Device Record Key

2cf2bbaf-7aad-4f1f-9a26-ad28e4a1f6d2

Public Version Date

May 06, 2020

Public Version Number

6

DI Record Publish Date

October 01, 2016

Package DI Number

30705031230860

Quantity per Package

5

Contains DI Package

10705031230866

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX