Swivel 5-6 mm universal tool adapter leg up

GUDID 07290113780705

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290113780705
• NIH Device Record Key: fdc305da-22d6-41c7-ac0e-c12032d09946
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swivel 5-6 mm universal tool adapter leg up
• Version Model Number: AMCRMU05
• Company DUNS: 600325755
• Company Name: AUGMEDICS LTD
• 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	07290113780705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190929

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

[07290113780705]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-23
• Device Publish Date: 2020-09-15

On-Brand Devices [Swivel 5-6 mm universal tool adapter leg up]

• 07290113780705: AMCRMU05
• 07290113780675: AMCRMD05