05001094

GUDID 07611819809819

MAINTENANCE KIT FOR EPD MAINTENANCE STATION

Synthes GmbH

Surgical instrument maintenance lubricant

• Primary Device ID: 07611819809819
• NIH Device Record Key: 77be257c-91bb-41d7-b7f6-c1c3074ef53a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 05.001.094
• Catalog Number: 05001094
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819809819 [Direct Marking]
GS1	10886982129147 [Primary]
HIBCC	H679050010940 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043310

FDA Product Code

• DZI: DRILL, BONE, POWERED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-25
• Device Publish Date: 2016-06-30

Devices Manufactured by Synthes GmbH

• 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
• 10886982349088 - NA: 2025-02-26 TERMITE REDUCTION FORCEPS SERRATED JAW
• H6792050550 - NA: 2025-02-20 3.5MM CANNULATED SCREW PARTIALLY THREADED/55MM
• H6794089050 - NA: 2025-02-20 7.3MM TI CANNULATED SCREW 16MM THREAD/105MM