03647985

GUDID H981036479850

SCREW REMOVAL BLADE

Synthes GmbH

Orthopaedic implant/instrument dismantling device

• Primary Device ID: H981036479850
• NIH Device Record Key: 5ae44136-0262-4daa-beb7-9855270802b5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.647.985
• Catalog Number: 03647985
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819404519 [Direct Marking]
GS1	10705034720845 [Primary]
HIBCC	H981036479850 [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

[H981036479850]

Moist Heat or Steam Sterilization

[H981036479850]

Moist Heat or Steam Sterilization

[H981036479850]

Moist Heat or Steam Sterilization

[H981036479850]

Moist Heat or Steam Sterilization

[H981036479850]

Moist Heat or Steam Sterilization

[H981036479850]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-01
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10886982322982 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 44MM T8
• 10886982322999 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 44MM T8 STERILE
• 10886982323002 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 46MM T8
• 10886982323019 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 46MM T8 STERILE
• 10886982323026 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 48MM T8
• 10886982323033 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 48MM T8 STERILE
• 10886982323040 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 50MM T8
• 10886982323057 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 50MM T8 STERILE