SkyWalker MPS10147

GUDID 00850030914323

Microport Navibot International LLC

Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use Imaging lesion localization marker, external, single-use

• Primary Device ID: 00850030914323
• NIH Device Record Key: 24fbfdf3-3527-42ea-a07b-d2bfae713262
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SkyWalker
• Version Model Number: NB-10147
• Catalog Number: MPS10147
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850030914323 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213873

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-07
• Device Publish Date: 2023-06-29

On-Brand Devices [SkyWalker]

• 20850030914280: Nail Box (2)
• 20850030914273: Long Pin Box (2)
• 20850030914266: Standard Pin Box (2)
• 00850030914323: NB-10147
• 00850030914316: Long Pin-Nail Kit
• 00850030914309: Standard Pin-Nail Kit