Esi

FDA UDI

Class II (US FDA UDI)

by Ftt Medical, Inc.

Identity

Trade Name: ESI FDA UDI
Generic Name: Haemorrhoid ligator FDA UDI
Device Name: MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE, 100 RINGS AND ANGLED FORCEPS. (Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions) FDA UDI
Model / Reference: 37-0810C FDA UDI
Description: MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE, 100 RINGS AND ANGLED FORCEPS. (Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions) FDA UDI

Identifiers

Primary DI / UDI-DI: B396370810C0 FDA UDI
FDA Product Code: FHN FDA UDI
GMDN Term: Haemorrhoid ligator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Haemorrhoid ligator

Esi by Ftt Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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ELMED INCORPORATED — ELMED INCORPORATED · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Ftt Medical, Inc.

Sources (1)

FDA UDI 0f942e51-4a06-4993-8b46-f38e163457e3 33 fields · synced May 30, 2026