Eba2

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: EBA2 FDA UDI
Generic Name: Cannulated surgical drill bit, reusable FDA UDI
Model / Reference: Cannulated drill bit FDA UDI

Identifiers

Catalog Number: EBA-5205 FDA UDI
Primary DI / UDI-DI: 08032909627851 FDA UDI
510(k) Number: K131005 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Cannulated surgical drill bit, reusable 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: Cannulated surgical drill bit, reusable

Eba2 by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cannulated surgical drill bit, reusable.

Thunderbolt — RESPONSIVE ORTHOPEDICS LLC · Class I
4.0 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc · Class II
GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
DynaNail — Medshape, Inc. · Class I
BIXCUT — Stryker Corp. · Class I
FREE GLIDING SCFE SCREW SYSTEM — Orthopediatrics Canada ULC · Class I
Tornier Perform — TORNIER, INC. · Class I

Cleared under the same submission

K131005 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 0af0da38-fba9-4bd5-b809-30fa817e8747 36 fields · synced May 30, 2026