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Ngenius

FDA UDI

Class II (US FDA UDI)

by Stryker Leibinger

Identity

Trade Name
NGENIUS FDA UDI
Generic Name
Patient positioning sensor FDA UDI
Device Name
NGENIUS TIBIA TRACKER FDA UDI
Model / Reference
6003-024-000 FDA UDI
Description
NGENIUS TIBIA TRACKER FDA UDI

Identifiers

Catalog Number
6003-024-000 FDA UDI
Primary DI / UDI-DI
04546540678676 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Patient positioning sensor 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Patient positioning sensor

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

Similar devices

Also classified as Patient positioning sensor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Leibinger

Sources (1)

  • FDA UDI a698da79-78d3-477b-9611-8a9941ada1a0 35 fields · synced Jun 7, 2026