Integra® First Choice® TRL-600-H190

GUDID M269TRL600H1901

The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluating congurency and joint articulation.

Ascension Orthopedics, Inc.

Surgical implant template, reusable

• Primary Device ID: M269TRL600H1901
• NIH Device Record Key: af821061-7a0f-470f-b3ab-fd34c478a68c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® First Choice®
• Version Model Number: TRL600H190
• Catalog Number: TRL-600-H190
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• 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	10381780236733 [Primary]
HIBCC	M269TRL600H1901 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112481

FDA Product Code

• KXE: PROSTHESIS, WRIST, HEMI-, ULNAR

Sterilization

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

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

[M269TRL600H1901]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-12-11
• Device Publish Date: 2016-08-15

On-Brand Devices [Integra® First Choice®]

• M269TRL600S651: The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating con
• M269TRL600S551: The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating con
• M269TRL600S451: The Modular Ulnar Head Stem Trial is used to determine the proper implant size by evaluating con
• M269TRL600MED1: The Modular Ulnar Head Collar trial attaches to a trial stem to adapt for a medium or long osteo
• M269TRL600LNG1: The Modular Ulnar Head Collar trial attaches to a trial stem to adapt for a medium or long osteo
• M269TRL600H1901: The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluatin
• M269TRL600H1751: The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluatin
• M269TRL600H1601: The Modular Ulnar Head Head Trial is used to determine the proper implant head size by evaluatin
• M269TRL610H190S651: The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a
• M269RL610H190S451: The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a
• M269RL610H175S651: The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a
• M269RL610H175S551: The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint a
• M268FRSTDRUJINSP1: The Integra First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint