nvc

GUDID 90814008024356

ACIF Encoded 14X16 6mm 6 Degree

NVISION BIOMEDICAL TECHNOLOGIES, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 90814008024356
• NIH Device Record Key: 002c23d9-4f27-423d-9859-5aad1cc67c7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nvc
• Version Model Number: ACE-606-L
• Company DUNS: 047486041
• Company Name: NVISION BIOMEDICAL TECHNOLOGIES, 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: 210-545-3713
• Email: diana@nvisionbiomed.com
• Phone: 210-545-3713
• Email: diana@nvisionbiomed.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 Identifiers

Device Issuing Agency	Device ID
GS1	90814008024356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142328

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[90814008024356]

Moist Heat or Steam Sterilization

[90814008024356]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-05-15

On-Brand Devices [nvc]

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• 00814008023233: Case Base, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023226: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023219: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023202: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023196: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
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• 00814008023172: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
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• 00814008023110: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023103: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
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• 00814008023080: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023073: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023066: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023059: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023042: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023035: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008023028: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
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• 00814008023004: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008022991: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
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• 00814008022977: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008022960: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
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• 00814008022946: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008022939: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008022922: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008022915: Instrument, Rasp, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008022908: Instrument, Trial, Anterior Cervical Interbody Fusion System (ACIF)
• 00814008022892: Instrument, Trial, Anterior Cervical Interbody Fusion System (ACIF)
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