← Back to catalogue

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 ENABLE FDA UDI
Model / Reference
6000-660-300 FDA UDI
Description
CRANIALMAP ENABLE FDA UDI

Identifiers

Catalog Number
6000-660-300 FDA UDI
Primary DI / UDI-DI
07613327327175 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

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

Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI 030d2d30-4640-46cc-ae20-0a0995be0ee6 34 fields · synced Jun 1, 2026