SD03233005

GUDID 10886982344472

INSERTION HANDLE ROTATING RFNA AIMING ARM

Synthes GmbH

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 10886982344472
• NIH Device Record Key: 583834fc-62fc-4d45-9fab-db63295541e3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD03.233.005
• Catalog Number: SD03233005
• 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
• 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	10886982344472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201346

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

[10886982344472]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-15
• Device Publish Date: 2023-12-07

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