31119

GUDID H679311190

TAP FOR 2.0MM CORTEX SCREWS 54MM

Synthes GmbH

Bone tap, single-use, non-sterile

• Primary Device ID: H679311190
• NIH Device Record Key: a96f1d5b-1ead-43c8-8362-ac0cc3ffb78a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 311.19
• Catalog Number: 31119
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: true
• 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: true
• 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
• 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
• 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	10886982187291 [Primary]
HIBCC	H679311190 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150796

FDA Product Code

• DZJ: DRIVER, WIRE, AND BONE DRILL, MANUAL

Sterilization

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

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

[H679311190]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-04-29
• Device Publish Date: 2018-07-18

Devices Manufactured by Synthes GmbH

• 10886982350039 - NA: 2025-08-15 CRE DRILL GUIDE 15MM
• 10886982350046 - NA: 2025-08-15 CRE DRILL GUIDE 18MM
• 10886982350053 - NA: 2025-08-15 CRE DRILL GUIDE 20MM
• 10886982350060 - NA: 2025-08-15 CRE DRILL GUIDE 25MM
• 10886982350077 - NA: 2025-08-15 7.0MM CAN TAP LARGE QUICK COUPLING
• 07612334226747 - NA: 2025-07-31 LID 2/3 SIZE STAINLESS STEEL
• 07612334227980 - NA: 2025-07-31 TRAY FOR OPERACE, 1 FROM 2
• 07612334228352 - NA: 2025-07-31 TRAY FOR OPERACE, 2 FROM 2