| Primary Device ID | M269INS1006001 |
| NIH Device Record Key | b25017da-f339-40b6-a419-c67badbba501 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TiWedge™ |
| Version Model Number | INS-1006-00 |
| Company DUNS | 942377524 |
| Company Name | Ascension Orthopedics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780237693 [Primary] |
| HIBCC | M269INS1006001 [Secondary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
[M269INS1006001]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-08 |
| Device Publish Date | 2016-08-08 |
| M269INS1006001 | The Integra® Titanium Bone Wedge Inserter is attached to the selected wedge implant and insert |
| M269TRL1006C061 | The Integra Titanium Bone Wedges are a series of wedge-shaped devices intended to be used for an |
| M269TRL1006C051 | The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the |
| M269TRL1006C041 | The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the |
| M269TRL1006C031 | The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the |
| M269TRL1006C021 | The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the |
| M269TRL1006C011 | The Integra® Titanium Cotton Wedge Trials are inserted until the footprint is congruent to the |
| M269TRL1006L091 | The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim |
| M269TRL1006L081 | The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim |
| M269TRL1006L071 | The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim |
| M269TRL1006L061 | The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim |
| M269TRL1006L051 | The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim |
| M269TRL1006L041 | The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim |
| M269TRL1006L031 | The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim |
| M269TRL1006L021 | The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim |
| M269TRL1006L011 | The Integra® Titanium Bone WedgeTrials are inserted until the footprint is congruent to the dim |