EPS Plating System

FDA UDI

Class I (US FDA UDI)

by Gramercy Extremity Orthopedics, Llc.

Identity

Trade Name: EPS Plating System FDA UDI
Generic Name: Surgical drill guide, single-use FDA UDI
Device Name: Locking Drill Guide, EPS Plates FDA UDI
Model / Reference: 22200019 FDA UDI
Description: Locking Drill Guide, EPS Plates FDA UDI

Identifiers

Primary DI / UDI-DI: B471222000190 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical drill guide, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical drill guide, single-use

EPS Plating System by Gramercy Extremity Orthopedics, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Gramercy Extremity Orthopedics, Llc.

Sources (1)

FDA UDI 958c5643-ff26-4970-9df0-4767e1d0cbc3 35 fields · synced May 30, 2026