N/A NB-M0020058

GUDID 10850030914146

Knee Kit Sterilization Tray

Microport Navibot International LLC

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