Catalog Number

-

Brand Name

Spetzler™ Lighted Suction Tube, 9 French, 160mm long

Version/Model Number

DN1509-160

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

ec497622-a58f-48a3-b42a-c5906b9c85aa

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-