Catalog Number

-

Brand Name

Single Use Rotatable Clip Fixing Device

Version/Model Number

HX-201UR-135

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

MND

Product Code Name

Ligator, esophageal

Public Device Record Key

67957b1c-639d-428e-aec3-6147b97f4c6d

Public Version Date

May 24, 2022

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

14953170353113

Quantity per Package

20

Contains DI Package

04953170353116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-