Primary Device ID | M2482270011 |
NIH Device Record Key | 2421df11-15c2-4960-b7a2-baf001acaa80 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Katalyst™ Bipolar Radial Head System |
Version Model Number | 227001 |
Catalog Number | 227001 |
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 | |
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 Issuing Agency | Device ID |
---|---|
GS1 | 10381780279693 [Primary] |
HIBCC | M2482270011 [Secondary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
[M2482270011]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-03-04 |
Device Publish Date | 2018-04-10 |
M2482259241 | Katalyst™ Bipolar Radial Head System 24mm Radial Head Sizing Wand |
M2482259211 | Katalyst™ Bipolar Radial Head System 21mm Radial Head Sizing Wand |
M2482259181 | Katalyst™ Bipolar Radial Head System 18mm Radial Head Sizing Wand |
M248KATALYSTWANDIMP1 | Katalyst Radial Head Sizing Wand Instruments |
M2482243241 | KATALYST TRIAL HEAD 24MM |
M2482243211 | KATALYST TRIAL HEAD 21MM |
M2482243181 | KATALYST TRIAL HEAD 18MM |
M2482241751 | TRIAL STEM SHAFT 7.5MM |
M2482241651 | TRIAL STEM SHAFT 6.5MM |
M2482240001 | DEMO IMPLANT, RADIAL HEAD |
M2482270011 | KATALYST NYLON DEMO HOLDER |
M2482253751 | 7.5MM BROACH LONG |
M2482253651 | 6.5MM BROACH LONG |
M2482260001 | Katalyst™ Bipolar Radial Head System STARTER AWL |
M2482259001 | Katalyst™ Bipolar Radial Head System HEAD SIZING TEMPLATE |
M2482256001 | Katalyst™ Bipolar Radial Head System CUTTING TEMPLATE |
M248225405KMI1 | Katalyst™ Bipolar Radial Head System FIRST SPACER |
M248225400KMI1 | Katalyst™ Bipolar Radial Head System SPACER 2MM |