05001010

GUDID 07611819167711

ELECTRIC PEN DRIVE 60,000 RPM

Synthes GmbH

Multi-purpose surgical power tool system, line-powered

• Primary Device ID: 07611819167711
• NIH Device Record Key: b2867ddf-dd27-4508-8257-6192461e75e1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 05.001.010
• Catalog Number: 05001010
• 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
• 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	07611819167711 [Direct Marking]
GS1	10886982128201 [Primary]
HIBCC	H679050010100 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043310

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

[07611819167711]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-04-18
• Device Publish Date: 2016-06-30

Devices Manufactured by Synthes GmbH

• 07612334226747 - NA: 2025-07-31 LID 2/3 SIZE STAINLESS STEEL
• 07612334227980 - NA: 2025-07-31 TRAY FOR OPERACE, 1 FROM 2
• 07612334228352 - NA: 2025-07-31 TRAY FOR OPERACE, 2 FROM 2
• 10886982348982 - NA: 2025-07-24 Ø12.8MM HOLLOW REAMER
• 10886982349835 - NA: 2025-07-24 WRENCH / 11MM SLOTTED SOCKET
• 10886982350121 - NA: 2025-07-24 FEMORAL GONIOMETER
• 10886982350152 - NA: 2025-07-24 5TH MET WIRE GUIDE
• 10886982350428 - NA: 2025-07-24 TENS BENDING EXTRACTOR