Universal 2™ Total Wrist System 262301

GUDID M2482623011

The Universal 2 Total Wrist carpal-poly component is a titanium ‘plate’ which is fixed into the carpal bones with a cemented central peg and two titanium screws.

INTEGRA LIFESCIENCES CORPORATION

Total wrist prosthesis

Primary Device ID	M2482623011
NIH Device Record Key	3dccc19f-72c3-4403-912b-3c86b4cd2159
Commercial Distribution Status	In Commercial Distribution
Brand Name	Universal 2™ Total Wrist System
Version Model Number	262301
Catalog Number	262301
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
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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Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780066002 [Primary]
HIBCC	M2482623011 [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.