EXPert

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: EXPert FDA UDI
Generic Name: Surgical depth gauge, reusable FDA UDI
Device Name: SPIRAL BLADE MEASURING DEVICE FOR EXPERT RAFN FDA UDI
Model / Reference: 03.010.492 FDA UDI
Description: SPIRAL BLADE MEASURING DEVICE FOR EXPERT RAFN FDA UDI

Identifiers

Catalog Number: 03010492 FDA UDI
Primary DI / UDI-DI: 10886982069092 FDA UDI
510(k) Number: K033618 FDA UDI
FDA Product Code: HWC FDA UDI
HSB FDA UDI
GMDN Term: Surgical depth gauge, reusable FDA UDI

Classification

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical depth gauge, reusable

EXPert by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical depth gauge, reusable.

Depth Gauge — I.T.S. GmbH · Class I
FO NX Nail System — FIELD ORTHOPAEDICS PTY LTD · Class I
FO Micro Screw System — FIELD ORTHOPAEDICS PTY LTD · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
Trigen — Smith & Nephew, Inc. · Class I
HOOK TIP DEPTH GAUGE CLAVICLE SYSTEM — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I

Cleared under the same submission

K033618 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Synthes

Sources (1)

FDA UDI 39354a7f-2229-4c75-8a74-3bdbe850c849 36 fields · synced May 30, 2026