Hive Standalone ALIF System 06-A-0002-4015

GUDID 00817493023870

32W x 26L x 15H, 8° - Peel Pouch Packaging Configuration

Nanohive Medical LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00817493023870
• NIH Device Record Key: d452bb87-6512-46bc-9bc0-4649fbde3999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hive Standalone ALIF System
• Version Model Number: 06-A-0002-4015
• Catalog Number: 06-A-0002-4015
• Company DUNS: 080469093
• Company Name: Nanohive Medical 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com
• Phone: 844-943-5433
• Email: customerservice@nanohive.com

Device Dimensions

• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree
• Width: 32 Millimeter
• Length: 26 Millimeter
• Height: 15 Millimeter
• Angle: 8 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817493023870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200541

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

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: 2023-09-08
• Device Publish Date: 2023-08-31

On-Brand Devices [Hive Standalone ALIF System]

• 00817493024167: 32W x 26L x 19H, 22° - Peel Pouch Packaging Configuration
• 00817493024150: 32W x 26L x 17H, 22° - Peel Pouch Packaging Configuration
• 00817493024143: 32W x 26L x 15H, 22° - Peel Pouch Packaging Configuration
• 00817493024136: 32W x 26L x 13H, 22° - Peel Pouch Packaging Configuration
• 00817493024112: 38W x 26L x 19H, 22° - Peel Pouch Packaging Configuration
• 00817493024105: 38W x 26L x 17H, 22° - Peel Pouch Packaging Configuration
• 00817493024099: 38W x 26L x 15H, 22° - Peel Pouch Packaging Configuration
• 00817493024082: 38W x 26L x 13H, 22° - Peel Pouch Packaging Configuration
• 00817493024068: 38W x 26L x 19H, 15° - Peel Pouch Packaging Configuration
• 00817493024051: 38W x 26L x 17H, 15° - Peel Pouch Packaging Configuration
• 00817493024044: 38W x 26L x 15H, 15° - Peel Pouch Packaging Configuration
• 00817493024037: 38W x 26L x 13H, 15° - Peel Pouch Packaging Configuration
• 00817493023993: 38W x 26L x 17H, 8° - Peel Pouch Packaging Configuration
• 00817493023986: 38W x 26L x 15H, 8° - Peel Pouch Packaging Configuration
• 00817493023979: 38W x 26L x 13H, 8° - Peel Pouch Packaging Configuration
• 00817493023931: 32W x 26L x 17H, 15° - Peel Pouch Packaging Configuration
• 00817493023924: 32W x 26L x 15H, 15° - Peel Pouch Packaging Configuration
• 00817493023917: 32W x 26L x 13H, 15° - Peel Pouch Packaging Configuration
• 00817493023900: 32W x 26L x 11H, 15° - Peel Pouch Packaging Configuration
• 00817493023887: 32W x 26L x 17H, 8° - Peel Pouch Packaging Configuration
• 00817493023870: 32W x 26L x 15H, 8° - Peel Pouch Packaging Configuration
• 00817493023863: 32W x 26L x 13H, 8° - Peel Pouch Packaging Configuration
• 00817493023856: 32W x 26L x 11H, 8° - Peel Pouch Packaging Configuration