Accumatch

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name: Accumatch FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: Special 4.5mm Drill Guide FDA UDI
Model / Reference: SPI-008506 FDA UDI
Description: Special 4.5mm Drill Guide FDA UDI

Identifiers

Catalog Number: SPI-008506 FDA UDI
Primary DI / UDI-DI: 10885862634948 FDA UDI
FDA Product Code: JDI FDA UDI
HWC FDA UDI
JWH FDA UDI
MBH FDA UDI
LPH FDA UDI
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3040 FDA UDI
888.3560 FDA UDI
888.3565 FDA UDI
888.3358 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

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

Accumatch by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical drill guide, reusable.

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Legion — Smith & Nephew, Inc. · Class II
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ACUFEX — Smith & Nephew, Inc. · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I

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: Exactech, Inc.

Sources (1)

FDA UDI 68300f2c-51e0-441b-b8f7-9a775a0a2797 34 fields · synced May 30, 2026