05001180

GUDID 07611819319585

IRRIGATION NOZZLE F/PEN DRIVE F/PERFORATOR W/HUDSON COUPLING

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: 07611819319585
• NIH Device Record Key: 620ede18-3e1e-49b7-ac51-8fd87f045ff5
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 05.001.180
• Catalog Number: 05001180
• 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	07611819319585 [Direct Marking]
GS1	10886982129543 [Primary]
HIBCC	H679050011800 [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

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

Moist Heat or Steam Sterilization

[07611819319585]

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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• 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