Rondo'

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: RONDO' FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Model / Reference: Cannula for drill ø2.1mm FDA UDI

Identifiers

Catalog Number: VP-92521 FDA UDI
Primary DI / UDI-DI: 08056711928685 FDA UDI
510(k) Number: K113388 FDA UDI
FDA Product Code: HTY FDA UDI
HTN FDA UDI
HWC FDA UDI
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 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

Dimensions & Sizes

Size: Outer Diameter — 2.1 Millimeter FDA UDI

Category: Surgical drill guide, reusable

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

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Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · Class I

Cleared under the same submission

K113388 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 8bf085b1-329a-4a12-b6d6-a55c2ef38ff6 37 fields · synced May 30, 2026