OS2®-V

GUDID 03760225710814

Varisation staple Inox

IN2BONES

Orthopaedic bone staple, non-adjustable

• Primary Device ID: 03760225710814
• NIH Device Record Key: fbc9b38a-274a-4082-b1f0-15f19dd97ed0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OS2®-V
• Version Model Number: T10 SS268
• Company DUNS: 263616749
• Company Name: IN2BONES
• 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: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com
• Phone: +33472292626
• Email: contact@in2bones.com

Device Dimensions

• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree
• Device Size Text, specify: 0
• Angle: 26 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760225710814 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143323

FDA Product Code

• JDR: Staple, Fixation, Bone

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: 2021-11-23
• Device Publish Date: 2015-08-28

On-Brand Devices [OS2®-V]

• 03760225710838: Varisation staple Inox
• 03760225710821: Varisation staple Inox
• 03760225710814: Varisation staple Inox
• 03760225710807: Varisation staple Inox