DIEGO® STARLINK HANDPIECE FOR USE W/BRAINLAB IGS SYSTEMS

GUDID 00821925026148

"70338010 DIEGO STARLINK HANDPIECE"

Gyrus Acmi, Inc.

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• Primary Device ID: 00821925026148
• NIH Device Record Key: 6ba8b371-0d22-40f8-8fa0-ade9893bd8ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIEGO® STARLINK HANDPIECE FOR USE W/BRAINLAB IGS SYSTEMS
• Version Model Number: 70338010
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925026148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030343

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

[00821925026148]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-12

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• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG