Integra® NuGrip® TRL-443-10S

GUDID M269TRL44310S1

The NuGrip Trial is used to evaluate the size and fit of the implant.

Ascension Orthopedics, Inc.

Carpometacarpal interpositional spacer prosthesis trial

• Primary Device ID: M269TRL44310S1
• NIH Device Record Key: e5dfd562-5cdf-467e-b5af-a53f4db92b8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® NuGrip®
• Version Model Number: TRL44310S
• Catalog Number: TRL-443-10S
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• 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 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780236511 [Primary]
HIBCC	M269TRL44310S1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112278

FDA Product Code

• KYI: PROSTHESIS, WRIST, CARPAL TRAPEZIUM

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

[M269TRL44310S1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-09-25
• Device Publish Date: 2016-08-15

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