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Eba One

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name
EBA ONE FDA UDI
Generic Name
Fluted surgical drill bit, single-use FDA UDI
Model / Reference
Graduated drill bit, ø4.2x315mm (STERILE) FDA UDI

Identifiers

Catalog Number
EBA-5297 FDA UDI
Primary DI / UDI-DI
08051739539769 FDA UDI
510(k) Number
K183666 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Fluted surgical drill bit, single-use 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

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

No

FDA UDI

Category: Fluted surgical drill bit, single-use

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

Similar devices

Also classified as Fluted surgical drill bit, single-use.

Cleared under the same submission

K183666 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Citieffe

Sources (1)

  • FDA UDI c149f2ba-f23d-4f2f-a35b-694b1b04a63d 36 fields · synced May 30, 2026