Catalog Number

AL8000

Brand Name

Hemorrhoid Ligator

Version/Model Number

AL8000

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)

Yes

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

-

Product Code

FHN

Product Code Name

Ligator, Hemorrhoidal

Public Device Record Key

13d12800-738e-45cf-948e-17e9a3e86817

Public Version Date

October 09, 2019

Public Version Number

1

DI Record Publish Date

October 01, 2019

Package DI Number

00850348007342

Quantity per Package

25

Contains DI Package

00850348007335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-