Integra® NuGrip® CMCCUTRINSTP
GUDID M248CMCCUTRINSTP1
CMC Implant Cutters
Ascension Orthopedics, Inc.
Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable| Primary Device ID | M248CMCCUTRINSTP1 |
| NIH Device Record Key | 2cb8b9b1-d08a-4e37-88ee-e6cecec35d61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Integra® NuGrip® |
| Version Model Number | CMCCUTRINSTP |
| Catalog Number | CMCCUTRINSTP |
| 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 | false |
| Serial Number | true |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780282433 [Primary] |
| HIBCC | M248CMCCUTRINSTP1 [Secondary] |
FDA Product Code
| HTZ | INSTRUMENT, CUTTING, ORTHOPEDIC |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
[M248CMCCUTRINSTP1]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-03-04 |
| Device Publish Date | 2018-04-13 |
On-Brand Devices [Integra® NuGrip®]
| 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 |
Trademark Results [Integra]
© 2024 FDA.report
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