| Primary Device ID | M2482645201 |
| NIH Device Record Key | 7570e7fb-a2a2-4daf-9606-b871c6cecea6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Universal 2™ Total Wrist System |
| Version Model Number | 264520 |
| Catalog Number | 264520 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
| 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 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 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 Size Text, specify | 0 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780064886 [Primary] |
| HIBCC | M2482645201 [Secondary] |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
[M2482645201]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-02-26 |
| Device Publish Date | 2017-10-09 |
| 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. |