N/A NB-M0020058

GUDID 10850030914146

Knee Kit Sterilization Tray

Microport Navibot International LLC

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 10850030914146
• NIH Device Record Key: 03253eed-876d-439c-b183-f04452c654ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: E.Z.4641-NB
• Catalog Number: NB-M0020058
• Company DUNS: 118104014
• Company Name: Microport Navibot International LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850030914149 [Primary]
GS1	10850030914146 [Package]; Contains: 00850030914149; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213873

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

[10850030914146]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-25
• Device Publish Date: 2022-12-08

On-Brand Devices [N/A]

• 00850030914064: Tunnel Guide
• 00850030914040: Fixation Component
• 10850030914283: Nail Pouched
• 10850030914276: Long Pin Pouched
• 10850030914269: Standard Pin Pouched
• 10850030914146: Knee Kit Sterilization Tray
• 00850030914118: Osteotomy Probe Probe L Type