Primary Device ID | M2483035021 |
NIH Device Record Key | 03a556ad-47e2-44dd-bafe-e08516f3bf21 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Integra® Total Wrist Fusion System |
Version Model Number | 303502 |
Catalog Number | 303502 |
Company DUNS | 963856096 |
Company Name | INTEGRA LIFESCIENCES CORPORATION |
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 | |
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 | |
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 |
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Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
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Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
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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 | 10381780281047 [Primary] |
HIBCC | M2483035021 [Secondary] |
FSM | TRAY, SURGICAL, INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
[M2483035021]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-10-21 |
Device Publish Date | 2018-04-13 |
M2483035111 | INSTRUMENT CASE BASE (EMEA) |
M2483035101 | INSTRUMENT CASE COMPLETE - EMEA |
M2483035051 | INSTRUMENT CASE IMPLANT CADDY LID (US) |
M2483035041 | INSTRUMENT CASE LID (US/EMEA) |
M2483035031 | INSTRUMENT CASE IMPLANT CADDY (US) |
M2483035021 | INSTRUMENT CASE TOP LEVEL (US/EMEA) |
M2483035011 | INSTRUMENT CASE BASE (US) |
M2483035001 | INSTRUMENT CASE COMPLETE - US |
M248303328CS1 | Total Wrist Fusion cortical screw |
M248303326CS1 | Total Wrist Fusion cortical screw |
M248303324CS1 | Total Wrist Fusion cortical screw |
M248303322CS1 | Total Wrist Fusion cortical screw |
M248303320CS1 | Total Wrist Fusion cortical screw |
M248303318CS1 | Total Wrist Fusion cortical screw |
M248303316CS1 | Total Wrist Fusion cortical screw |
M248303314CS1 | Total Wrist Fusion cortical screw |
M248303312CS1 | Total Wrist Fusion cortical screw |
M248303224CS1 | Total Wrist Fusion cortical screw |
M248303222CS1 | Total Wrist Fusion cortical screw |
M248303220CS1 | Total Wrist Fusion cortical screw |
M248303218CS1 | Total Wrist Fusion cortical screw |
M248303216CS1 | Total Wrist Fusion cortical screw |
M248303214CS1 | Total Wrist Fusion cortical screw |
M248303212CS1 | Total Wrist Fusion cortical screw |
M248303210CS1 | Total Wrist Fusion cortical screw |
M248303102S1 | The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with |
M248303101S1 | The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with |
M248303100S1 | The Integra Total Wrist Fusion straight plate with nine holes is fixed to the bone with screws. |
M2483033261 | Total Wrist Fusion cortical screw |
M2483033241 | Total Wrist Fusion cortical screw |
M2483033221 | Total Wrist Fusion cortical screw |
M2483033181 | Total Wrist Fusion cortical screw |
M2483033141 | Total Wrist Fusion cortical screw |
M2483032241 | Total Wrist Fusion cortical screw |
M2483032221 | Total Wrist Fusion cortical screw |
M2483032201 | Total Wrist Fusion cortical screw |
M2483032181 | Total Wrist Fusion cortical screw |
M2483032161 | Total Wrist Fusion cortical screw |
M2483032141 | Total Wrist Fusion cortical screw |
M2483031021 | The Integra Total Wrist Fusion pre-contoured plates with eight holes are fixed to the bone with |
M2483033201 | Total Wrist Fusion cortical screw |
M268WRISTFUSESET0 | The Total Wrist Fusion System (WRISTFUSEEST) consists of two pre-contoured plates with eight hol |