EXPert 03010501

GUDID H679030105010

12.0MM PROTECTION SLEEVE FOR EXPERT TIBIA NAIL/QC

Synthes GmbH

Orthopaedic implantation sleeve, reusable

• Primary Device ID: H679030105010
• NIH Device Record Key: 20d875f4-3914-48d1-8017-f1ffb8ebe822
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPert
• Version Model Number: 03.010.501
• Catalog Number: 03010501
• 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	07611819498983 [Direct Marking]
GS1	10886982069184 [Primary]
HIBCC	H679030105010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040762

FDA Product Code

• JDS: NAIL, FIXATION, BONE

Sterilization

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

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

[H679030105010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• 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