Swivel 3-4 mm universal tool adapter Leg up

GUDID 07290113780996

AUGMEDICS LTD

Multi-purpose stereotactic surgery system

• Primary Device ID: 07290113780996
• NIH Device Record Key: ad80f2c9-5e4a-48dd-b341-a4f3e44d43ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Swivel 3-4 mm universal tool adapter Leg up
• Version Model Number: AMCRMU03
• 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	07290113780996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220905

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

[07290113780996]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2022-12-13

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