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NavitrackER

FDA UDI

Class II (US FDA UDI)

by Orthosoft Inc

Identity

Trade Name
NavitrackER FDA UDI
Generic Name
Imaging lesion localization marker, external, single-use FDA UDI
Model / Reference
20-8000-000-07 FDA UDI

Identifiers

Catalog Number
20-8000-000-07 FDA UDI
Primary DI / UDI-DI
00889024304222 FDA UDI
510(k) Number
K030827 FDA UDI
K060336 FDA UDI
K071714 FDA UDI
K071929 FDA UDI
K110054 FDA UDI
FDA Product Code
OLO FDA UDI
HAW FDA UDI
GMDN Term
Imaging lesion localization marker, external, 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Imaging lesion localization marker, external, single-use

NavitrackER by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Imaging lesion localization marker, external, single-use.

Cleared under the same submission

K030827 also covers:

K060336 also covers:

K071714 also covers:

K071929 also covers:

K110054 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthosoft Inc

Sources (1)

  • FDA UDI 6ac582cb-b589-4c27-b44c-dbc5f2894c22 35 fields · synced May 30, 2026