Universal 2™ Total Wrist System 264525

GUDID M2482645251

The Universal 2 Total Wrist cancellous bone screw implant.

Ascension Orthopedics, Inc.

Total wrist prosthesis
Primary Device IDM2482645251
NIH Device Record Key96757849-c9ac-48b9-af23-763bab6c9134
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal 2™ Total Wrist System
Version Model Number264525
Catalog Number264525
Company DUNS942377524
Company NameAscension Orthopedics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone800-654-2873
Emailcustsvnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish.
Special Storage Condition, SpecifyBetween 0 and 0 *Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 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 AgencyDevice ID
GS110381780064893 [Primary]
HIBCCM2482645251 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


[M2482645251]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-03-04
Device Publish Date2017-10-09

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

M2482645251The Universal 2 Total Wrist cancellous bone screw implant.
M2482645151The Universal 2 Total Wrist cancellous bone screw implant.

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