Primary Device ID | M269BRH10040D1 |
NIH Device Record Key | 1cb487fe-8fd1-4dd0-94d6-79f77c4744a4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ascension® |
Version Model Number | BRH10040D |
Catalog Number | BRH-100-40D |
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 | true |
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 |
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 | 10381780242253 [Primary] |
HIBCC | M269BRH10040D1 [Secondary] |
HTQ | BROACH |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
[M269BRH10040D1]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-08-07 |
Device Publish Date | 2017-08-30 |
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 |