Primary Device ID | 10381780364696 |
NIH Device Record Key | 8a5529bd-882b-488e-922f-9fdd87e12ee7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Integra® NuGrip® |
Version Model Number | CSA44306 |
Catalog Number | CSA-443-06 |
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 | |
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 | 10381780364696 [Primary] |
OJH | Orthopedic tray |
Steralize Prior To Use | true |
Device Is Sterile | false |
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
[10381780364696]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-12-23 |
Device Publish Date | 2019-12-13 |
10381780364696 | CMC Implant NuGrip Trial Caddy Lid |
M269SHP443S1 | The Finishing Shaper is used to shape the implant. |
M269SHP443M1 | The Finishing Shaper is used to shape the implant. |
M269SHP443L1 | The Finishing Shaper is used to shape the implant. |
M269TRL44340M1 | The NuGrip Trial is used to evaluate the size and fit of the implant. |
M269TRL44340L1 | The NuGrip Trial is used to evaluate the size and fit of the implant. |
M269TRL44330S1 | The NuGrip Trial is used to evaluate the size and fit of the implant. |
M269TRL44330M1 | The NuGrip Trial is used to evaluate the size and fit of the implant. |
M269TRL44330L1 | The NuGrip Trial is used to evaluate the size and fit of the implant. |
M269TRL44320S1 | The NuGrip Trial is used to evaluate the size and fit of the implant. |
M269TRL44320M1 | The NuGrip Trial is used to evaluate the size and fit of the implant. |
M269TRL44310S1 | The NuGrip Trial is used to evaluate the size and fit of the implant. |
M269TRL44310M1 | The NuGrip Trial is used to evaluate the size and fit of the implant. |
M248CMCCUTRINSTP1 | CMC Implant Cutters |
10381780364689 | CMC Implant, NuGrip Trial Caddy |
M268NUGRIPINSTP1 | The Integra NuGrip system is intended to replace the proximal end of the first metacarpal in cas |