Eba One

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: EBA ONE FDA UDI
Generic Name: Surgical drill guide obturator FDA UDI
Model / Reference: Obturator for trocar for stabilization wire FDA UDI

Identifiers

Catalog Number: EBA-5397 FDA UDI
Primary DI / UDI-DI: 08056711929262 FDA UDI
510(k) Number: K183666 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Surgical drill guide obturator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide obturator

Eba One by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide obturator.

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JUGGERKNOT FLEX OBTURATOR — Biomet Orthopedics, Inc. · Class II
NexFix — TORNIER, INC. · Class I
AM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
NexFix — TORNIER, INC. · Class I

Cleared under the same submission

K183666 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: Citieffe

Sources (1)

FDA UDI d5ac01d3-ae10-463c-98a8-6b07479339dd 36 fields · synced May 31, 2026