Neuro & Craniofacial Fixation System

GUDID M711CR021BR0

CP Ti

Innovasis, Inc.

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• Primary Device ID: M711CR021BR0
• NIH Device Record Key: 6b0ba39b-13fb-43ff-bbbf-ab2cba7e9b89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuro & Craniofacial Fixation System
• Version Model Number: CR021BR
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• Device Count: 1
• DM Exempt: true
• 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: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Dimensions

• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711CR021BR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091679

FDA Product Code

• JEY: Plate, Bone

Sterilization

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

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

[M711CR021BR0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2017-07-31

On-Brand Devices [Neuro & Craniofacial Fixation System]

• M711CRT16040: Ti 6Al 4V (ELI)
• M711CRT14050: Ti 6Al 4V (ELI)
• M711CRT14040: Ti 6Al 4V (ELI)
• M711CRT14030: Ti 6Al 4V (ELI)
• M711CRT106DY0: CP Ti
• M711CRT104ST0: CP Ti
• M711CRT104SQ0: CP Ti
• M711CRT102ST0: CP Ti
• M711CRT100UT030: CP Ti
• M711CRT042BR0: CP Ti
• M711CRT041BR0: CP Ti
• M711CRT040BR0: CP Ti
• M711CRT032BR0: CP Ti
• M711CRT031BR0: CP Ti
• M711CRT030BR0: CP Ti
• M711CRT020GP0: CP Ti
• M711CRT006ST0: CP Ti
• M711CRT006DY0: CP Ti
• M711CRT004ST0: CP Ti
• M711CRT004SQ0: CP Ti
• M711CRT002ST0: CP Ti
• M711CR19040: Ti 6Al 4V (ELI)
• M711CR16050: Ti 6Al 4V (ELI)
• M711CR16040: Ti 6Al 4V (ELI)
• M711CR16030: Ti 6Al 4V (ELI)
• M711CR104SQ0: CP Ti
• M711CR102ST0: CP Ti
• M711CR100MD060: CP Ti
• M711CR030GP0: CP Ti
• M711CR021BR0: CP Ti
• M711CR020GP0: CP Ti
• M711CR020BR0: CP Ti
• M711CR011BR0: CP Ti
• M711CR010GP0: CP Ti
• M711CR010BR0: CP Ti
• M711CR006ST0: CP Ti
• M711CR006DY0: CP Ti
• M711CR004ST0: CP Ti
• M711CR004SQ0: CP Ti
• M711CR002ST0: CP Ti
• M711BTA1410: Al
• M711BTA1400: Al
• M711BTA1390: Al, Radel
• M711BTA1380: Al
• M711BTA1370: Al
• M711BTA1360: Al
• M711BTA1350: Al
• M711BTA1340: Al, Radel
• M711LS5720: Sterilized Electric Screw Driver, Cranial, Plastic, electronics, SST