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Disposable Emr Kit

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
DISPOSABLE EMR KIT FDA UDI
Generic Name
Endoscopic electrosurgical submucosal lift/resection set FDA UDI
Device Name
DISPOSABLE EMR KIT FDA UDI
Model / Reference
K-006 FDA UDI
Description
DISPOSABLE EMR KIT FDA UDI

Identifiers

Primary DI / UDI-DI
04953170137433 FDA UDI
FDA Product Code
FDS FDA UDI
GMDN Term
Endoscopic electrosurgical submucosal lift/resection set 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

Yes

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: Endoscopic electrosurgical submucosal lift/resection set

Disposable Emr Kit by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic electrosurgical submucosal lift/resection set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Olympus Medical Systems Corporation

Sources (1)

  • FDA UDI 40fc59e2-fd09-4eb1-a79c-c71043e14111 34 fields · synced Jun 8, 2026