Catalog Number

1204-01

Brand Name

Viper

Version/Model Number

1204-01

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"

Yes

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

-

Product Code

KNQ

Product Code Name

Dilator, Esophageal

Public Device Record Key

f1e2d53f-52da-43a0-8c92-fb29d04ce407

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Package DI Number

10816734021818

Quantity per Package

5

Contains DI Package

00816734021811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case