ESI - MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE, - FTT MEDICAL, INC.

Duns Number:002212793

Device Description: MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE, 100 RINGS AND ANGLED FORCEPS. (Caution: T MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE, 100 RINGS AND ANGLED FORCEPS. (Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions)

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More Product Details

Catalog Number

-

Brand Name

ESI

Version/Model Number

37-0810C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FHN

Product Code Name

Ligator, Hemorrhoidal

Device Record Status

Public Device Record Key

0f942e51-4a06-4993-8b46-f38e163457e3

Public Version Date

September 18, 2019

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FTT MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 113