RTS Surgical Instruments

GUDID 00817906020045

Flexible Great Toe Implant, surgical instruments

IN2BONES USA, LLC

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• Primary Device ID: 00817906020045
• NIH Device Record Key: 9a9473df-ca21-4c00-92e2-751241dcc12b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RTS Surgical Instruments
• Version Model Number: M03 S0002
• 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: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com
• Phone: 901.260.7931
• Email: info@i2b-usa.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817906020045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153609

FDA Product Code

• KWH: Prosthesis, Toe, Constrained, Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-11-05

On-Brand Devices [RTS Surgical Instruments]

• 00817906020069: Flexible Great Toe Implant, surgical instruments
• 00817906020052: Flexible Great Toe Implant, surgical instruments
• 00817906020045: Flexible Great Toe Implant, surgical instruments