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Cross Element Guide Sleeve TO-FIX-CEGS

by Toby Orthopaedics

Cross Element Guide Sleeve TO-FIX-CEGS is a Class I device made by Toby Orthopaedics, listed in FDA GUDID since 28 Aug 2020 (UDI-DI 00816101010370), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816101010370 UDI-DI Date28 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Cross Element Guide Sleeve
Generic name
General external orthopaedic fixation system implantation kit, reusable
Catalogue number
TO-FIX-CEGS
Primary DI / UDI-DI
00816101010370
FDA product code
GCZ
GMDN term
General external orthopaedic fixation system implantation kit, reusable
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: General external orthopaedic fixation system implantation kit, reusable

Similar devices in this category

Other devices filed under General external orthopaedic fixation system implantation kit, reusable.

Other devices from Toby Orthopaedics

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Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)