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Epinaut

FDA UDI

Class II (US FDA UDI)

by Imedicom Co., Ltd.

Identity

Trade Name
EPINAUT FDA UDI
Generic Name
Anaesthesia conduction catheter FDA UDI
Model / Reference
C31011320 FDA UDI

Identifiers

Primary DI / UDI-DI
08809544172226 FDA UDI
510(k) Number
K173541 FDA UDI
FDA Product Code
BSO FDA UDI
GMDN Term
Anaesthesia conduction catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5120 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

Yes

FDA UDI

Category: Anaesthesia conduction catheter

Epinaut by Imedicom Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia conduction catheter.

Cleared under the same submission

K173541 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imedicom Co., Ltd.

Sources (1)

  • FDA UDI d7d4a1b2-3ccc-4c06-afc6-b48f9c7bdca9 33 fields · synced Jun 8, 2026