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UNiD™ Calibration Sphere

FDA UDI

Class I (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name
UNiD™ Calibration Sphere FDA UDI
Generic Name
Radiological image marker, noninvasive, reusable FDA UDI
Device Name
SPHERE A00300032 UNID CALIBRATION SPHERE FDA UDI
Model / Reference
A00300032 FDA UDI
Description
SPHERE A00300032 UNID CALIBRATION SPHERE FDA UDI

Identifiers

Primary DI / UDI-DI
03613720287971 FDA UDI
FDA Product Code
JAC FDA UDI
GMDN Term
Radiological image marker, noninvasive, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiological image marker, noninvasive, reusable

UNiD™ Calibration Sphere by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological image marker, noninvasive, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI 580bf83a-ffdf-48dc-8ddf-8257ad84108e 34 fields · synced Jun 1, 2026