SD03511342

GUDID 10887587077840

1.4MM TROCAR DRILL BIT W/ J-LATCH - CALIBRATED

Synthes GmbH

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable

• Primary Device ID: 10887587077840
• NIH Device Record Key: dd647f5a-aca7-4bc6-b036-d092485606fe
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD03.511.342
• Catalog Number: SD03511342
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587077840 [Primary]

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

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

[10887587077840]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-18
• Device Publish Date: 2022-08-10

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• 10886982344250 - NA: 2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP
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• 10886982346933 - NA: 2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA