05001111

GUDID 07611819798205

IRRIGATION NOZZLE FOR EPD HEX DRILLING ATTACHMENT

SYNTHES (U.S.A.) LP

Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set Surgical irrigation/aspiration tubing set

• Primary Device ID: 07611819798205
• NIH Device Record Key: ce0025fe-3a84-47fa-81e9-5cebc274524d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 05.001.111
• Catalog Number: 05001111
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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	07611819798205 [Direct Marking]
GS1	10886982129338 [Primary]
HIBCC	H679050011110 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043310

FDA Product Code

• DZI: DRILL, BONE, POWERED

Sterilization

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

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

[07611819798205]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-06-30

Devices Manufactured by SYNTHES (U.S.A.) LP

• H981023060100 - NA: 2024-07-12 6.0MM PELVIC ROD-LEFT
• H981023060120 - NA: 2024-07-12 6.0MM PELVIC ROD-RIGHT
• H981042006140 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 28MM THREAD LENGTH
• H981042006150 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 30MM THREAD LENGTH
• H981042006160 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 32MM THREAD LENGTH
• H981042006170 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 34MM THREAD LENGTH
• H981042006180 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 36MM THREAD LENGTH
• H981042006190 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 38MM THREAD LENGTH