Catalog Number

S181

Brand Name

Single Use Surgical Professional

Version/Model Number

S181

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KCG

Product Code Name

Dilator, Tracheal

Public Device Record Key

74e6c147-8c20-42f7-9139-3c8a8bb35b84

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

August 09, 2016

Package DI Number

05055299103777

Quantity per Package

15

Contains DI Package

05055299103760

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton