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: General-purpose calliper, metallic FDA UDI
Device Name: CALIPER EX1211010 TIP, 25MM OFFSET FDA UDI
Model / Reference: EX1211010 FDA UDI
Description: CALIPER EX1211010 TIP, 25MM OFFSET FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169123243 FDA UDI
FDA Product Code: KTZ FDA UDI
GMDN Term: General-purpose calliper, metallic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4150 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: General-purpose calliper, metallic

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 General-purpose calliper, metallic.

Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
Symmetry House — SYMMETRY SURGICAL INC. · Class I
Salvin Dental Specialties — SALVIN DENTAL SPECIALTIES, LLC · Class I
CALIPER CASTROVIEJO 40mm FENSTRATED — W.H. Holden, Inc. · Class I
Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
CALIPER — KLS-Martin L.P. · Class I
CALIPER — KLS-Martin L.P. · Class I
Caliper — BURLINGTON MEDICAL, LLC · 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

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

Manufacturer

Manufacturer: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI e9fe1440-6892-4cf6-bb81-dfac841dc421 34 fields · synced May 30, 2026