Catalog Number

-

Brand Name

Single Use Grasping Forceps

Version/Model Number

FG-804L

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

K200342,K200342

Product Code

EOB

Product Code Name

Nasopharyngoscope (flexible or rigid)

Public Device Record Key

a2866abf-2ce5-4a2f-9baa-f5d27f350567

Public Version Date

July 01, 2021

Public Version Number

1

DI Record Publish Date

June 23, 2021

Package DI Number

14953170435871

Quantity per Package

1

Contains DI Package

04953170435874

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-