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Cross Element Guide Sleeve

FDA UDI

Class I (US FDA UDI)

by Toby Orthopaedics

Identity

Trade Name
Cross Element Guide Sleeve FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, reusable FDA UDI
Device Name
Guides are stainless steel parts of various designs that allow various drill diameters. Some guides are laser weld assemblies with a handle, and others are threaded to screw into plates. FDA UDI
Model / Reference
NA FDA UDI
Description
Guides are stainless steel parts of various designs that allow various drill diameters. Some guides are laser weld assemblies with a handle, and others are threaded to screw into plates. FDA UDI

Identifiers

Catalog Number
TO-FIX-CEGS FDA UDI
Primary DI / UDI-DI
00816101010370 FDA UDI
FDA Product Code
GCZ FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
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

No

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

Yes

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

Category: General external orthopaedic fixation system implantation kit, reusable

Cross Element Guide Sleeve by Toby Orthopaedics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General external orthopaedic fixation system implantation kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Toby Orthopaedics

Sources (1)

  • FDA UDI 57568f34-a144-471e-b89d-e7292e9b57be 34 fields · synced May 30, 2026