03647971

GUDID H981036479710

REMOVAL SCREWDRIVER

Synthes GmbH

Surgical screwdriver, reusable

• Primary Device ID: H981036479710
• NIH Device Record Key: 8dd70d34-50a5-4aa8-b153-7fbae8f66643
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.647.971
• Catalog Number: 03647971
• 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	07611819404472 [Direct Marking]
GS1	10705034720791 [Primary]
HIBCC	H981036479710 [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

[H981036479710]

Moist Heat or Steam Sterilization

[H981036479710]

Moist Heat or Steam Sterilization

[H981036479710]

Moist Heat or Steam Sterilization

[H981036479710]

Moist Heat or Steam Sterilization

[H981036479710]

Moist Heat or Steam Sterilization

[H981036479710]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2022-06-01
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10886982349095 - NA: 2025-03-06 PLATE HOLDING FORCEPS LEFT FLARED TIPS
• 10886982349101 - NA: 2025-03-06 PLATE HOLDING FORCEPS RIGHT FLARED TIPS
• 10886982348265 - NA: 2025-03-05 XL IM REDUCTION TOOL CURVED WITH AO REAMER COUPLING
• 10887587078427 - NA: 2025-02-28 1.85MM ORTHOGNATHIC TAP
• 10886982344410 - NA: 2025-02-26 MAXFRAME CONTROL BOX TEMPLATE
• 10886982348333 - NA: 2025-02-26 1.1MM PARALLEL WIRE GUIDE
• 10886982348364 - NA: 2025-02-26 1.4MM PARALLEL WIRE GUIDE
• 10886982348395 - NA: 2025-02-26 1.6MM PARALLEL WIRE GUIDE