Bendini

GUDID 00887517246837

Bendini Digitizer Array

Nuvasive, Inc.

Spinal rod bending system

• Primary Device ID: 00887517246837
• NIH Device Record Key: 464626b4-cc80-4f04-84ea-f66d481a57a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bendini
• Version Model Number: 1570780
• Company DUNS: 053950783
• Company Name: Nuvasive, 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: false
• 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(858)909-1800
• Email: RA_UDI@nuvasive.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887517246837 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111811

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

On-Brand Devices [Bendini]

• 00887517470638: Bendini Instrument Tray
• 00887517467423: Bendini 5.5 Rod Bender and Pointers
• 00887517285294: Bendini Pointer, Closed Head
• 00887517285287: Bendini Guideless Pointer, Adjustable
• 00887517285270: Bendini Guide Pointer
• 00887517285263: Bendini Guide Pointer, Adjustable
• 00887517270207: Bendini Hybrid Pointer
• 00887517246332: Bendini Rod Bender, Spinal
• 00887517193957: Bendini Rod Bender II, Spinal
• 00887517172532: Rod Bending Digitizer Array
• 00887517107787: Bendini Swivel Pointer
• 00887517094698: Bendini Cable Box
• 00887517246837: Bendini Digitizer Array
• 00887517141132: Bendini IR Probe Passive Sphere, 5 Pack
• 00887517690975: Bendini Pointer, OCT Lock Screw
• 00887517690968: Bendini Pointer, OCT Open
• 00887517672278: Bendini Pointer, OCT Connector
• 00887517740601: Bendini 3.5/5.5 Rod Bender and Pointers
• 00887517728203: Bendini Template, Rod Hinged
• 00887517721457: Bendini Trauma Pointer
• 00887517672438: Bendini Rod Bender OCT, Spinal
• 00887517672261: Bendini Pointer, OCT Hybrid
• 00887517665751: Bendini 5.5/6.0 Rod Bender and Pointers
• 00887517605078: Bendini ASF Pointer
• 00887517605054: Bendini Adjustable Open Pointer
• 00887517101235: NDI Vicra USB Converter, 4.5m Comm Cable
• 00887517086068: Bendini Cable, USB A-B
• 00887517221155: Bendini Base, Rod Bender II Tray
• 00887517246820: Beta Bendini Instrument Base Tray