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Gpc

FDA UDI

Class II (US FDA UDI)

by Gpc Medical, Ltd.

Identity

Trade Name
GPC FDA UDI
Generic Name
Custom-made upper limb fixation plate FDA UDI
Device Name
Self-Tapping Cortex Screw 4.5 mm, Hexagonal Socket - Titanium FDA UDI
Model / Reference
736.16T FDA UDI
Description
Self-Tapping Cortex Screw 4.5 mm, Hexagonal Socket - Titanium FDA UDI

Identifiers

Primary DI / UDI-DI
08905892061936 FDA UDI
510(k) Number
K092493 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
GMDN Term
Custom-made upper limb fixation plate 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made upper limb fixation plate

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

Similar devices

Also classified as Custom-made upper limb fixation plate.

Cleared under the same submission

K092493 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gpc Medical, Ltd.

Sources (1)

  • FDA UDI 9163fb8d-7c19-4fdd-9208-fccdf5608a02 35 fields · synced Jun 1, 2026