Primary Device ID | M269TRL600S651 |
NIH Device Record Key | 346a9d17-93b6-4e5a-947d-ec15430c593f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Integra® First Choice® |
Version Model Number | TRL600S65 |
Catalog Number | TRL-600-S65 |
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 |
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 | 10381780236788 [Primary] |
HIBCC | M269TRL600S651 [Secondary] |
HWT | TEMPLATE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
[M269TRL600S651]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 6 |
Public Version Date | 2020-12-11 |
Device Publish Date | 2016-08-15 |
M269TRL600S651 | The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating con |
M269TRL600S551 | The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating con |
M269TRL600S451 | The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating con |
M269TRL600MED1 | The Modular Ulnar Head Collar trial attaches to a trial stem to adapt for a medium or long osteo |
M269TRL600LNG1 | The Modular Ulnar Head Collar trial attaches to a trial stem to adapt for a medium or long osteo |
M269TRL600H1901 | The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluatin |
M269TRL600H1751 | The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluatin |
M269TRL600H1601 | The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluatin |
M269TRL610H190S651 | The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a |
M269RL610H190S451 | The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a |
M269RL610H175S651 | The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a |
M269RL610H175S551 | The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a |
M268FRSTDRUJINSP1 | The Integra First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint |