Catalog Number

A.5650

Brand Name

Haemorrhoid ligator

Version/Model Number

A.5650

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

K070881,K070881

Product Code

FHN

Product Code Name

Ligator, Hemorrhoidal

Public Device Record Key

8442dee8-6261-4c94-b938-ca9dace3afad

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 25, 2016

Package DI Number

08033638800294

Quantity per Package

25

Contains DI Package

08033638800287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-