NeoSpan™ SuperElastic Compression Staple w/Instruments

GUDID 00810021861371

Sterile, Size 20x15x15

IN2BONES USA, LLC

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• Primary Device ID: 00810021861371
• NIH Device Record Key: a13621cc-6528-43ed-93dd-82ea548838b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoSpan™ SuperElastic Compression Staple w/Instruments
• Version Model Number: T50 SN120
• Company DUNS: 079700711
• Company Name: IN2BONES USA, 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: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com
• Phone: 9012607931
• Email: info@i2b-usa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021861371 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161426

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2019-09-30
• Device Publish Date: 2019-09-20

On-Brand Devices [NeoSpan™ SuperElastic Compression Staple w/Instruments]

• 00810021861371: Sterile, Size 20x15x15
• 00810021861364: Sterile, Size 18x14x14