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Gps

FDA UDI

Class II (US FDA UDI)

by Exactech, Inc.

Identity

Trade Name
GPS FDA UDI
Generic Name
Orthopaedic stereotactic surgery system FDA UDI
Device Name
GPS COLLARED 3.2MM DRILL RTG FDA UDI
Model / Reference
02-521-78-0000 FDA UDI
Description
GPS COLLARED 3.2MM DRILL RTG FDA UDI

Identifiers

Catalog Number
02-521-78-0000 FDA UDI
Primary DI / UDI-DI
10885862564801 FDA UDI
510(k) Number
K100742 FDA UDI
K152764 FDA UDI
K193618 FDA UDI
FDA Product Code
OLO FDA UDI
HAW FDA UDI
GMDN Term
Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
Not 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Gps by Exactech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K100742 also covers:

K152764 also covers:

K193618 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Exactech, Inc.

Sources (1)

  • FDA UDI 5f69d461-44dd-4928-94a0-10ea74eb68bf 36 fields · synced May 31, 2026