Universal 2™ Total Wrist System 264535S

GUDID M248264535S1

The Universal 2 Total Wrist cancellous bone screw implant.

INTEGRA LIFESCIENCES CORPORATION

Total wrist prosthesis

• Primary Device ID: M248264535S1
• NIH Device Record Key: 5060ed3f-b6ea-42a3-a6c9-e0b9bca162b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal 2™ Total Wrist System
• Version Model Number: 264535S
• Catalog Number: 264535S
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• 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(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780066255 [Primary]
HIBCC	M248264535S1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030037

FDA Product Code

• JWJ: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-26
• Device Publish Date: 2017-10-09

On-Brand Devices [Universal 2™ Total Wrist System]

• M268UNI2SET0: The UNI2SET is the Universal 2 Total Wrist set intended for cement fixation. The system consists
• M248264535S1: The Universal 2 Total Wrist cancellous bone screw implant.
• M248264530S1: The Universal 2 Total Wrist cancellous bone screw implant.
• M248264525S1: The Universal 2 Total Wrist cancellous bone screw implant.
• M248264520S1: The Universal 2 Total Wrist cancellous bone screw implant.
• M268263800RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263800LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263700RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263700LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263600RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263600LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263500RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M268263500LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263400RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263400LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263300RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263300LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263200RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263200LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263100RT1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M248263100LF1: The Universal 2 Total Wrist radial component has a concave articulating surface and is fixed by
• M2482624021: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482624011: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482624001: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482623021: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482623011: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482623001: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482622021: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482622011: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482622001: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482621021: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482621011: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482621001: The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into
• M2482614011: The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
• M2482613011: The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
• M2482612011: The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
• M2482611011: The Universal 2 Total Wrist carpal component is a titanium ‘plate’ which is fixed into the c
• M2482645351: The Universal 2 Total Wrist cancellous bone screw implant.
• M2482645301: The Universal 2 Total Wrist cancellous bone screw implant.
• M2482645201: The Universal 2 Total Wrist cancellous bone screw implant.
• M248264515S1: The Universal 2 Total Wrist cancellous bone screw implant.