Catalog Number

-

Brand Name

MT

Version/Model Number

HMBLS- XL-7F-NL

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

3c1b3fad-106f-4dc9-aca4-3161f5668d34

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

16932503532225

Quantity per Package

1

Contains DI Package

06932503532228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box