05001064

GUDID 07611819926356

ADAPTOR F/MAINTENANCE UNIT F/ XL & XXL ATTACH FOR PEN DRIVE

Synthes GmbH

Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor Surgical power tool adaptor

• Primary Device ID: 07611819926356
• NIH Device Record Key: e55dd4c5-b03b-4dca-8ddc-4cf8dfd7e4bd
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 05.001.064
• Catalog Number: 05001064
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819926356 [Direct Marking]
GS1	10886982128874 [Primary]
HIBCC	H679050010640 [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: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-18
• Device Publish Date: 2016-06-30

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• 10887587078366 - NA: 2024-05-22 BONE PUSHER
• 10886982344229 - NA: 2024-05-13 FOOT - 10MM UPRIGHT REDUCTION CLAMP
• 10886982344236 - NA: 2024-05-13 FOOT - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344243 - NA: 2024-05-13 HOOK - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344250 - NA: 2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP
• 10886982346940 - NA: 2024-05-09 60MM DEPTH PROBE FOR XL25 SCREWS
• 10886982346933 - NA: 2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA