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EPS Plating System Screw

FDA UDI

Class II (US FDA UDI)

by Gramercy Extremity Orthopedics, Llc.

Identity

Trade Name
EPS Plating System Screw FDA UDI
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Device Name
Plate Screw Non-Locking Cancellous 4.0mm x 55mm, EPS FDA UDI
Model / Reference
11034055 FDA UDI
Description
Plate Screw Non-Locking Cancellous 4.0mm x 55mm, EPS FDA UDI

Identifiers

Primary DI / UDI-DI
B471110340550 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 4.0 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

The EPS Plating System Screw is a non-labelling, non-sterile plate screw used for internal orthopaedic fracture fixation. It features a 4.0mm outer diameter and 55mm length, making it suitable for various applications.

Similar devices

Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gramercy Extremity Orthopedics, Llc.

Sources (1)

  • FDA UDI 863aa1c1-3423-45a0-bc79-389b5c3bf6d0 36 fields · synced Jul 3, 2026