CONTACT® IBF PEEK VBR/IBF SYSTEM 34-A30-10-0

GUDID 00846468035952

INTERBODY FUSION DEVICE / VERTEBRAL SPACER

Pioneer Surgical Technology, Inc.

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00846468035952
• NIH Device Record Key: c1e10014-6e04-4ceb-98d5-b620267ecd69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTACT® IBF PEEK VBR/IBF SYSTEM
• Version Model Number: 34-A30-10-0
• Catalog Number: 34-A30-10-0
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, Inc.
• 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: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com
• Phone: +1(386)418-8888
• Email: labeling@rtix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846468035952 [Primary]
GS1	00846468091453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133455

FDA Product Code

• MQP: Spinal vertebral body replacement device
• ODP: Intervertebral fusion device with bone graft, cervical

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: 2018-11-06
• Device Publish Date: 2018-10-06

On-Brand Devices [CONTACT® IBF PEEK VBR/IBF SYSTEM]

• 00846468036188: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036065: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468036027: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468035983: INTERBODY FUSION DEVICE / VERTEBRAL SPACER
• 00846468035952: INTERBODY FUSION DEVICE / VERTEBRAL SPACER