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Single Use Ligating Device

FDA UDI

Class II (US FDA UDI)

by Olympus Medical Systems Corporation

Identity

Trade Name
SINGLE USE LIGATING DEVICE FDA UDI
Generic Name
Polypectomy endoscopic ligator, single-use FDA UDI
Model / Reference
HX-400U-30 FDA UDI

Identifiers

Catalog Number
N5382130 FDA UDI
Primary DI / UDI-DI
04953170368615 FDA UDI
FDA Product Code
MND FDA UDI
GMDN Term
Polypectomy endoscopic ligator, single-use 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Polypectomy endoscopic ligator, single-use

Single Use Ligating Device by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polypectomy endoscopic ligator, single-use.

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 9b3539a4-ab1a-47e0-82fc-4b46aeaa74f9 34 fields · synced Jun 1, 2026