Primary Device ID | M2483034071 |
NIH Device Record Key | feadc459-22fb-43c5-84b4-182dc0b08515 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Integra® Total Wrist Fusion System |
Version Model Number | 303407 |
Catalog Number | 303407 |
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 | true |
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 |
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 | 10381780281108 [Primary] |
HIBCC | M2483034071 [Secondary] |
HTJ | GAUGE, DEPTH |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
[M2483034071]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2021-03-04 |
Device Publish Date | 2018-04-13 |
M2483034021 | 2.7 MM DRILL BIT |
M2483034011 | 2.5 MM DRILL BIT |
M2483034001 | 2.0 MM DRILL BIT |
M2483034521 | SHORT BEND PLATE TRIAL |
M2483034511 | STANDARD BEND PLATE TRIAL |
M2483034501 | STRAIGHT PLATE TRIAL |
M2483034071 | DEPTH GAUGE |
M2483034121 | PLATE BENDER 3.5 MM HOLE |
M2483034111 | PLATE BENDER 2.7 MM HOLE |
M2483034101 | 2.0 MM, SELF RETAINING HEX DRIVER |
M2483034091 | 2.5 MM, SELF RETAINING HEX DRIVER |
M2483034081 | SELF RETAINING STAR DRIVER |
M2483034061 | 3.5MM THREADED DRILL GUIDE 2.7 MM DRILL BIT |
M2483034051 | 2.7MM THREADED DRILL GUIDE 2.0 MM DRILL BIT |
M2483034041 | CORTICAL DOUBLE ENDED DRILL GUIDE 2.5 MM DRILL BIT |
M2483034031 | CORTICAL DOUBLE ENDED DRILL GUIDE 2.0 MM DRILL BIT |
M2483033281 | Total Wrist Fusion cortical screw |
M2483033161 | Total Wrist Fusion cortical screw |
M2483033121 | Total Wrist Fusion cortical screw |
M2483032121 | Total Wrist Fusion cortical screw |
M2483032101 | Total Wrist Fusion cortical screw |
M2483031011 | The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with |
M2483031001 | The Integra Total Wrist Fusion straight plate with nine holes is fixed to the bone with screws. |