Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name: FUJIFILM FDA UDI
Generic Name: Rigid video laparoscope FDA UDI
Device Name: FUJIFILM Video Laparoscope EL-R740M30 is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas. FDA UDI
Model / Reference: EL-R740M30 FDA UDI
Description: FUJIFILM Video Laparoscope EL-R740M30 is intended to be used with a video processor, light source, monitor, hand instruments, electrosurgical unit and other ancillary equipment for minimally invasive observation, diagnosis and treatment in general abdominal, gynecologic and thoracic areas. FDA UDI

Identifiers

Primary DI / UDI-DI: 04547410449723 FDA UDI
510(k) Number: K212950 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Rigid video laparoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid video laparoscope

Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II

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: FUJIFILM Corporation

Sources (1)

FDA UDI 9a041503-42da-4fb1-9afb-837b13f6912b 36 fields · synced May 31, 2026