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STELLAR Knee Marker Kit

FDA UDI

Class II (US FDA UDI)

by Polarisar, Inc.

Identity

Trade Name
STELLAR Knee Marker Kit FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
For use with TruFix Pin Kit (80-0005) FDA UDI
Model / Reference
80-0006 FDA UDI
Description
For use with TruFix Pin Kit (80-0005) FDA UDI

Identifiers

Catalog Number
80-0006 FDA UDI
Primary DI / UDI-DI
00850046497179 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

STELLAR Knee Marker Kit by Polarisar, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Polarisar, Inc.

Sources (1)

  • FDA UDI b345a59b-3bc2-4fc7-a016-3a33c978c302 35 fields · synced May 31, 2026