Catalog Number

-

Brand Name

SICKLE KNIFE DISPOSABLE SINUS ENDOSCOPY

Version/Model Number

130801

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K932988,K932988

Product Code

EOB

Product Code Name

NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Public Device Record Key

0ae0d7bf-6620-4a9e-9c3b-b8f6de90d655

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 28, 2016

Package DI Number

00821925016842

Quantity per Package

6

Contains DI Package

00821925040267

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-