Ascension® CSA50001
GUDID M269CSA500011
Ascension® PIP Silicone MCP The Silicone MCP Lid is the top part of the case which locks onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
Instrument tray| Primary Device ID | M269CSA500011 |
| NIH Device Record Key | fcc515ff-a6bd-447f-8f0c-ce4760b3aef5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ascension® |
| Version Model Number | CSA-500-01 |
| Catalog Number | CSA50001 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780243793 [Primary] |
| HIBCC | M269CSA500011 [Secondary] |
FDA Product Code
| OJH | Orthopedic tray |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
[M269CSA500011]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2017-08-30 |
On-Brand Devices [Ascension®]
| M269CSA100061 | Integra®Surgical Instruments The MCP Caddy is a smaller, removable container that rests within |
| M269CSA100051 | Integra®Surgical Instruments The Base is the bottom portion wherein devices are placed. |
| M269OSG10000P1 | Ascension® MCP Osteotomy Guide, Proximal |
| M269OSG10000D1 | Ascension® MCP Osteotomy Guide, Distal |
| M269IMP10000P1 | Ascension® MCP Proximal impactor |
| M269IMP10000D1 | Ascension® MCP Distal impactor |
| M269BRH10105P1 | MCP Proximal Cutting Broach Sz. 05 |
| M269BRH10105D1 | MCP Distal Cutting Broach Sz. 05 |
| M269BRH10040P1 | MCP, Broach, Proximal, Sz. 40 |
| M269BRH10040D1 | MCP, Broach, Distal, Sz. 40 |
| M269BRH10030P1 | MCP, Broach, Proximal, Sz. 30 |
| M269BRH10030D1 | MCP, Broach, Distal, Sz. 30 |
| M269BRH10020P1 | MCP, Broach, Proximal, Sz. 20 |
| M269BRH10020D1 | MCP, Broach, Distal, Sz. 20 |
| M269BRH10010P1 | MCP, Broach, Proximal, Sz. 10 |
| M269BRH10010D1 | MCP, Broach, Distal, Sz. 10 |
| M269TRL500401 | Ascension® Silicone MCP, SMCP Trial Size 40 |
| M269TRL500301 | Ascension® Silicone MCP, SMCP Trial Size 30 |
| M269TRL500201 | Ascension® Silicone MCP, SMCP Trial Size 20 |
| M269TRL500101 | Ascension® Silicone MCP, SMCP Trial Size 10 |
| M269TRL10140P1 | Ascension® MCP Proximal Metal Trial Size 40 |
| M269TRL10140D1 | Ascension® MCP Distal Metal Trial Size 40 |
| M269TRL10130P1 | Ascension® MCP Proximal Metal Trial Size 30 |
| M269TRL10130D1 | Ascension® MCP Distal Metal Trial Size 30 |
| M269TRL10120P1 | Ascension® MCP Proximal Metal Trial Size 20 |
| M269TRL10120D1 | Ascension® MCP Distal Metal Trial Size 20 |
| M269TRL10110P1 | Ascension® MCP Proximal Metal Trial Size 10 |
| M269TRL10110D1 | Ascension® MCP Distal Metal Trial Size 10 |
| M269TRL10105P1 | Ascension® MCP Proximal Metal Trial Size 05 |
| M269TRL10105D1 | Ascension® MCP Distal Metal Trial Size 05 |
| M269TRL500051 | Ascension® Silicone MCP, SMCP Trial Size 05 |
| M269CSA500021 | Ascension® PIP Silicone MCP The Silicone MCP Base is the bottom portion wherein devices are pla |
| M269CSA500011 | Ascension® PIP Silicone MCP The Silicone MCP Lid is the top part of the case which locks onto |
| M269TRL500501 | The Silicone MCP Trial is used to evaluate component collar contact on osteotomy and stem fit in |
| M269TRL10150P1 | The Proximal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit |
| M269TRL10150D1 | The Distal Metal Trial is used to evaluate component collar contact on osteotomy and stem fit in |
| M268SILMCPINSTP1 | The Ascension Silicone MCP is intended for replacement of the metacarpophalangeal (MCP) joint wh |
| M268PYROMCPINSTP1 | The Ascension MCP is indicated for use as a total joint replacement of index, long, ring, and sm |
Trademark Results [Ascension]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.