SD316440

GUDID H980SD3164400

1.0MM DRILL BIT/STRYKER J-LTCH WITH 3MM STOP/44.5MM

Synthes GmbH

Fluted surgical drill bit, reusable

• Primary Device ID: H980SD3164400
• NIH Device Record Key: b8632f94-3663-495a-b920-d28cfdf288d2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD316.440
• Catalog Number: SD316440
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587002378 [Primary]
HIBCC	H980SD3164400 [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

[H980SD3164400]

Moist Heat or Steam Sterilization

[H980SD3164400]

Moist Heat or Steam Sterilization

[H980SD3164400]

Moist Heat or Steam Sterilization

[H980SD3164400]

Moist Heat or Steam Sterilization

[H980SD3164400]

Moist Heat or Steam Sterilization

[H980SD3164400]

Moist Heat or Steam Sterilization

[H980SD3164400]

Moist Heat or Steam Sterilization

[H980SD3164400]

Moist Heat or Steam Sterilization

[H980SD3164400]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-25
• Device Publish Date: 2022-07-15

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• 10886982323019 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 46MM T8 STERILE
• 10886982323026 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 48MM T8
• 10886982323033 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 48MM T8 STERILE
• 10886982323040 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 50MM T8
• 10886982323057 - VOLT: 2024-10-18 2.7MM VOLT(TM) CORTEX SCREW 50MM T8 STERILE