Cross Element Guide Sleeve TO-FIX-CEGS

GUDID 00816101010370

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.

TOBY ORTHOPAEDICS

General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable General external orthopaedic fixation system implantation kit, reusable
Primary Device ID00816101010370
NIH Device Record Key57568f34-a144-471e-b89d-e7292e9b57be
Commercial Distribution StatusIn Commercial Distribution
Brand NameCross Element Guide Sleeve
Version Model NumberNA
Catalog NumberTO-FIX-CEGS
Company DUNS024163331
Company NameTOBY ORTHOPAEDICS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816101010370 [Primary]

FDA Product Code

GCZRetainer, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


[00816101010370]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-07
Device Publish Date2020-08-28

Devices Manufactured by TOBY ORTHOPAEDICS

00816101010295 - 2.5mm Drill Bit X 110mm2020-09-07 Drill Bits are of various diameters and lengths, and are made of Stainless Steel, heat-treated and passivated. Some drill bits h
00816101010318 - 2.5mm Hex Driver2020-09-07 Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver asse
00816101010325 - Cruciform Driver2020-09-07 Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver asse
00816101010332 - Square Driver2020-09-07 Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver asse
00816101010349 - Depth Gauge, 50mm2020-09-07 Depth Gauges are assemblies made from stainless steel parts, with an outer housing, and a scaled slide with tip to measure depth
00816101010356 - Cross Element Guide2020-09-07 Guides are stainless steel parts of various designs that allow various drill diameters. Some guides are laser weld assemblies wi
00816101010363 - Cross Element Guide Retainer2020-09-07 Guides are stainless steel parts of various designs that allow various drill diameters. Some guides are laser weld assemblies wi
00816101010370 - Cross Element Guide Sleeve2020-09-07Guides 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.
00816101010370 - Cross Element Guide Sleeve2020-09-07 Guides are stainless steel parts of various designs that allow various drill diameters. Some guides are laser weld assemblies wi

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