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Fujifilm

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
FUJIFILM FDA UDI
Generic Name
Endoscope tissue removal cap, single-use FDA UDI
Device Name
This hood is intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures. FDA UDI
Model / Reference
DH-17EN2 FDA UDI
Description
This hood is intended to be used in combination with the dedicated endoscope to maintain the field of view during endoscopic procedures. FDA UDI

Identifiers

Primary DI / UDI-DI
04547410450071 FDA UDI
510(k) Number
K212296 FDA UDI
FDA Product Code
FDF FDA UDI
FDS FDA UDI
GMDN Term
Endoscope tissue removal cap, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscope tissue removal cap, single-use

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

Similar devices

Also classified as Endoscope tissue removal cap, single-use.

Cleared under the same submission

K212296 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI 93f429c6-c3be-43cf-bf07-aec05ff2a6d8 36 fields · synced Jun 8, 2026