EXPert 03010510

GUDID H679030105100

MULTI HOLE WIRE GUIDE FOR EXPERT LFN

Synthes GmbH

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable

• Primary Device ID: H679030105100
• NIH Device Record Key: 8120b3f4-1f74-4fda-a226-5f8a3bf64d33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPert
• Version Model Number: 03.010.510
• Catalog Number: 03010510
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819499065 [Direct Marking]
GS1	10886982069269 [Primary]
HIBCC	H679030105100 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040336

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

[H679030105100]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-04-28
• Device Publish Date: 2015-09-14

On-Brand Devices [EXPert]

• H679030105100: MULTI HOLE WIRE GUIDE FOR EXPERT LFN
• H679030105090: MULTI HOLE WIRE GUIDE FOR EXPERT ALFN
• H679030105080: MULTI HOLE WIRE GUIDE FOR EXPERT ANTEGRADE FEMORAL NAIL
• H679030105070: MULTI HOLE WIRE GUIDE FOR EXPERT RETROGRADE FEMORAL NAIL
• H679030105050: 17.0MM PROTECTION SLEEVE FOR EXPERT LFN NAIL/QC
• H679030105040: 13.0MM PROTECTION SLEEVE FOR EXPERT ALFN/QC
• H679030105010: 12.0MM PROTECTION SLEEVE FOR EXPERT TIBIA NAIL/QC
• H679030104920: SPIRAL BLADE MEASURING DEVICE FOR EXPERT RAFN
• H679030104850: RADIOLUCENT INSERTION HANDLE FOR EXPERT TIBIA NAILS/23MM
• H679030104830: RADIOLUCENT RECON AIMING ARM FOR EXPERT ALFN
• H679030104820: RADIOLUCENT RECON AIMING ARM FOR EXPERT LFN
• H679030100040: COMPRESSION DEVICE/ FOR TI CANNULATED TIBIA NAILS-EX