05001184

GUDID 07611819414785

IRRIGATION NOZZLE FOR EPD AND APD FOR USE WITH 05.001.182

Synthes GmbH

Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device Surgical power tool irrigation-control device

• Primary Device ID: 07611819414785
• NIH Device Record Key: 1638f84b-5ea5-4f5f-93ab-0358c6a47e80
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 05.001.184
• Catalog Number: 05001184
• 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	07611819414785 [Direct Marking]
GS1	10886982129574 [Primary]
HIBCC	H679050011840 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093361

FDA Product Code

• HBB: MOTOR, DRILL, PNEUMATIC

Sterilization

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

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

Moist Heat or Steam Sterilization

[07611819414785]

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

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• 10887587078359 - NA: 2024-04-16 MANDIBLE BODY REDUCTION HANDLE