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: Orthopaedic bone calliper FDA UDI
Device Name: GAUGE 9090102 STRGHT CHISL DEPTH LONG FDA UDI
Model / Reference: 9090102 FDA UDI
Description: GAUGE 9090102 STRGHT CHISL DEPTH LONG FDA UDI

Identifiers

Primary DI / UDI-DI: 00673978958880 FDA UDI
FDA Product Code: HTJ FDA UDI
GMDN Term: Orthopaedic bone calliper FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4300 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: Orthopaedic bone calliper

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

Similar devices

Also classified as Orthopaedic bone calliper.

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LEG LENGTH CALIPER ASSY — Zimmer, Inc. · Class I
Novel — ALPHATEC SPINE, INC. · Class I
Cortera — Xtant Medical Holdings, Inc. · Class I
VerteFIT — Ldr Spine USA · Class I
Perfix™ MIS — CG MedTech Co., Ltd. · Class I
Bone Caliper — SUNCOAST DENTAL, INC. · Class I
Novo Surgical — NOVO SURGICAL, 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 I	Pending data

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Manufacturer

Manufacturer: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI 97d56f29-e645-4a1b-a8d7-9bae43286356 34 fields · synced Jun 8, 2026