Integra® First Choice® TRL-610-H175-S55

GUDID M269RL610H175S551

The DRUJ Trial is used to determine the proper implant size by evaluating congruency and joint articulation.

Ascension Orthopedics, Inc.

Surgical implant template, reusable

• Primary Device ID: M269RL610H175S551
• NIH Device Record Key: cbfd834e-7251-4276-806e-ae604d426cd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® First Choice®
• Version Model Number: RL610H175S55
• Catalog Number: TRL-610-H175-S55
• 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

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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780124443 [Primary]
HIBCC	M269RL610H175S551 [Secondary]

FDA Product Code

• HWT: TEMPLATE

Sterilization

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

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

[M269RL610H175S551]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• 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