04647834

GUDID H981046478340

3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 14MM

Synthes GmbH

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: H981046478340
• NIH Device Record Key: 29a97ff9-6580-4671-9709-f05e3fbb2c76
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.647.834
• Catalog Number: 04647834
• 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: 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
• 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	10705034751344 [Primary]
HIBCC	H981046478340 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112068

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

[H981046478340]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-26
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10886982348142 - NA: 2024-08-05 UNCANNULATED XL XL40 DRIVER
• 10887587078380 - NA: 2024-08-05 45 DEGREE TIP FLAT RIB FORCEPS, LEFT
• 10887587078397 - NA: 2024-08-05 90 DEGREE TIP FLAT RIB FORCEPS, LEFT
• 07612334292100 - NA: 2024-08-02 TRAY FOR REDUCTION AND SCREW INSERTION INSTRUMENTS
• 07612334292117 - NA: 2024-08-02 TRAY FOR LCP PLATES
• 07612334292124 - NA: 2024-08-02 SCREW CADDY
• 07612334292131 - NA: 2024-08-02 TRAY F/WIRE IMPL & INSTRUMENTS
• 10886982347466 - NA: 2024-08-02 RIGID INSERTION SLEEVE