PERLA TL Cortical NAV-Instruments NAV-IN 35 00-N

GUDID 07640450868695

PERLA TL NAV. DRILL Ø3.1

SpineArt SA

Bone tap, reusable

• Primary Device ID: 07640450868695
• NIH Device Record Key: 831f365d-4023-4aa3-ae8a-79b965723647
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERLA TL Cortical NAV-Instruments
• Version Model Number: NAV-IN 35 00-N
• Catalog Number: NAV-IN 35 00-N
• Company DUNS: 483016148
• Company Name: SpineArt SA
• 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: 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 Dimensions

• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter
• Outer Diameter: 3.1 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640450868695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210472

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

[07640450868695]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-06
• Device Publish Date: 2021-03-29

On-Brand Devices [PERLA TL Cortical NAV-Instruments ]

• 07640450868701: PERLA TL NAV. CORTICAL SCREWDRIVER SHAFT
• 07640450868695: PERLA TL NAV. DRILL Ø3.1
• 07640450868688: PERLA TL NAV. CORTICAL TAP Ø7.5 (Ø7.5 SCREW)
• 07640450868671: PERLA TL NAV. CORTICAL TAP Ø7.0
• 07640450868664: PERLA TL NAV. CORTICAL TAP Ø6.5 (Ø6.5 SCREW)
• 07640450868657: PERLA TL NAV. CORTICAL TAP Ø6.0 (Ø6.0 SCREW)
• 07640450868640: PERLA TL NAV. CORTICAL TAP Ø5.5 (Ø5.5 SCREW)
• 07640450868633: PERLA TL NAV. CORTICAL TAP Ø5.0 (Ø5.0 SCREW)
• 07640450868626: PERLA TL NAV. CORTICAL TAP Ø4.5 (Ø4.5 SCREW)