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Synergy

FDA UDI

Class II (US FDA UDI)

by Medtronic Navigation, Inc.

Identity

Trade Name
Synergy FDA UDI
Generic Name
Stereotactic surgery system workstation FDA UDI
Device Name
PLNG STATION 9734048 STEALTHSTATION S7 FDA UDI
Model / Reference
9734048 FDA UDI
Description
PLNG STATION 9734048 STEALTHSTATION S7 FDA UDI

Identifiers

Primary DI / UDI-DI
00613994532398 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Stereotactic surgery system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Stereotactic surgery system workstation

Synergy by Medtronic Navigation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stereotactic surgery system workstation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Navigation, Inc.

Sources (1)

  • FDA UDI ff4b3dbf-390e-4285-9589-673103563293 34 fields · synced May 30, 2026