Epimed

FDA UDI

Class II (US FDA UDI)

by Epimed International, Inc

Identity

Trade Name: Epimed FDA UDI
Generic Name: Epidural anaesthesia set, non-medicated FDA UDI
Device Name: Spirol® Close End 19g x 36" Epidural Set, Styletted FDA UDI
Model / Reference: 202-1936 FDA UDI
Description: Spirol® Close End 19g x 36" Epidural Set, Styletted FDA UDI

Identifiers

Catalog Number: 202-1936 FDA UDI
Primary DI / UDI-DI: 00818788021175 FDA UDI
510(k) Number: K981329 FDA UDI
FDA Product Code: BSO FDA UDI
GMDN Term: Epidural anaesthesia set, non-medicated 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 36 Inch FDA UDI
Catheter Gauge — 3.2 French FDA UDI

Category: Epidural anaesthesia set, non-medicated

Epimed by Epimed International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K981329 also covers:

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: Epimed International, Inc

Sources (1)

FDA UDI 8ece50a4-bb23-4b98-96eb-1530b69713ed 38 fields · synced Jun 7, 2026