Medtronic Reusable Instruments

FDA UDI

Class I (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: Medtronic Reusable Instruments FDA UDI
Generic Name: Bone trephine, reusable FDA UDI
Device Name: INSTRUMENT 893-511 T HNDL TREPHINE 10MM FDA UDI
Model / Reference: 893-511 FDA UDI
Description: INSTRUMENT 893-511 T HNDL TREPHINE 10MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00673978075143 FDA UDI
FDA Product Code: HWK FDA UDI
GMDN Term: Bone trephine, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

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: Bone trephine, reusable

Medtronic Reusable Instruments by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone trephine, reusable.

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ZOLL-DENTAL — Zoll-Dental · Class I
Borchardt Flat Trephine 5 mm Borchardt Shaft Ø 1.8 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I
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V. Mueller — STERIS CORPORATION · 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 I	Pending data

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Manufacturer

Manufacturer: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI 0a4e9f15-2b1f-4ff1-b0dd-3091455388dd 34 fields · synced Jun 1, 2026