Gpc

FDA UDI

Class II (US FDA UDI)

by Gpc Medical, Ltd.

Identity

Trade Name: GPC FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: 2.4 mm Variable Angle 2-Column Distal Radius, Width 22 mm, 6 Head Holes - Left/Right FDA UDI
Model / Reference: 3001.02R FDA UDI
Description: 2.4 mm Variable Angle 2-Column Distal Radius, Width 22 mm, 6 Head Holes - Left/Right FDA UDI

Identifiers

Primary DI / UDI-DI: 08905892142581 FDA UDI
510(k) Number: K210198 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Gpc by Gpc Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K210198 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Gpc Medical, Ltd.

Sources (1)

FDA UDI 93d0c8f0-e2b2-4e8d-b7d3-7e83d3227c70 35 fields · synced May 31, 2026