Catalog Number

-

Brand Name

Spetzler™ Lighted Suction Tube, 3 French, 160mm long

Version/Model Number

DN1503-160

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

K141781,K141781

Product Code

FST

Product Code Name

Light, Surgical, Fiberoptic

Public Device Record Key

66c7ceb0-8ab8-478c-b1ef-f1e8a5313eb7

Public Version Date

April 20, 2020

Public Version Number

5

DI Record Publish Date

August 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-