NBX 8006-00-00

GUDID B488800600000

NON-BRIDGING EXTERNAL FIXATOR WRIST

NUTEK ORTHOPAEDICS INC

External orthopaedic fixation system, single-use, sterile

• Primary Device ID: B488800600000
• NIH Device Record Key: 701d611a-6626-4201-87f4-8e132e355359
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NBX
• Version Model Number: 8006-00-00
• Catalog Number: 8006-00-00
• Company DUNS: 787238620
• Company Name: NUTEK ORTHOPAEDICS 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(954)779-1400
• Email: peter@nutekortho.com
• Phone: +1(954)779-1400
• Email: peter@nutekortho.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B488800600000 [Primary]

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[B488800600000]

Radiation Sterilization

[B488800600000]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-02

On-Brand Devices [NBX]

• B488830700000: NON-BRIDGING EXTERNAL FIXATOR HAND SHORT
• B488820700000: NON-BRIDGING EXTERNAL FIXATOR HAND LONG
• B488810700000: NON-BRIDGING EXTERNAL FIXATOR SHOULDER
• B488800600000: NON-BRIDGING EXTERNAL FIXATOR WRIST