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Cranialmap

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
CRANIALMAP FDA UDI
Generic Name
Surgical planning/navigation-enhancement system FDA UDI
Device Name
CRANIALMAP SALES DEMO FDA UDI
Model / Reference
81-81036 FDA UDI
Description
CRANIALMAP SALES DEMO FDA UDI

Identifiers

Catalog Number
81-81036 FDA UDI
Primary DI / UDI-DI
07613327327182 FDA UDI
FDA Product Code
HAW FDA UDI
GMDN Term
Surgical planning/navigation-enhancement system 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical planning/navigation-enhancement system

Cranialmap by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical planning/navigation-enhancement system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 1a3538fb-4f4b-456c-b563-29a4f4fae44d 34 fields · synced May 30, 2026