456338S

GUDID H679456338S0

10MM/125 DEG TI CANN TROCH FIXATION NAIL 380MM/RIGHT-STER

Synthes GmbH

Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail

• Primary Device ID: H679456338S0
• NIH Device Record Key: 36fbe36f-4174-4cf0-ae46-73a126f197e9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 456.338S
• Catalog Number: 456338S
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• 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	10886982227126 [Primary]
HIBCC	H679456338S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011857

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

[H679456338S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-02
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10887587078311 - NA: 2024-06-04 PLATE HOLDING FORCEPS WITH BALL AND FOOT
• 10887587078366 - NA: 2024-05-22 BONE PUSHER
• 10886982344229 - NA: 2024-05-13 FOOT - 10MM UPRIGHT REDUCTION CLAMP
• 10886982344236 - NA: 2024-05-13 FOOT - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344243 - NA: 2024-05-13 HOOK - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344250 - NA: 2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP
• 10886982346940 - NA: 2024-05-09 60MM DEPTH PROBE FOR XL25 SCREWS
• 10886982346933 - NA: 2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA