MatrixMANDIBLE

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: MatrixMANDIBLE FDA UDI
Generic Name: Fluted surgical drill bit, reusable FDA UDI
Device Name: MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/145MM F/03.503.042 FDA UDI
Model / Reference: 03.503.462 FDA UDI
Description: MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/145MM F/03.503.042 FDA UDI

Identifiers

Catalog Number: 03503462 FDA UDI
Primary DI / UDI-DI: 10887587012940 FDA UDI
510(k) Number: K043310 FDA UDI
FDA Product Code: DZI FDA UDI
GMDN Term: Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4120 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: Fluted surgical drill bit, reusable

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

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Cleared under the same submission

K043310 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: Synthes

Sources (1)

FDA UDI addbb751-cb2a-4312-92c5-649b9d586bbe 36 fields · synced Jun 8, 2026