Ascension® First Choice® DRUJ System DRUJ6101645WW

GUDID 10381780123576

The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ulnar head replacement. It has a distal articular head and proximal intramedullary stem. The cobalt chromium implant head articulates with the radius and the carpal bones of the wrist. These features match native ulnar head articulation. The implant is inserted into the medullary canal of the ulna following resection of the ulnar head. It is designed to be a press fit device that achieves fixation by means of direct implant/bone appositions.

Ascension Orthopedics, Inc.

Wrist ulna-head prosthesis

• Primary Device ID: 10381780123576
• NIH Device Record Key: c1a476a9-bda5-4cee-a1be-1a0ad4547087
• Commercial Distribution Discontinuation: 2026-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascension® First Choice® DRUJ System
• Version Model Number: DRUJ6101645WW
• Catalog Number: DRUJ6101645WW
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10381780123576 [Primary]
HIBCC	M268DRUJ6101645WW1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112481

FDA Product Code

• KXE: PROSTHESIS, WRIST, HEMI-, ULNAR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-02-22
• Device Publish Date: 2017-10-09

On-Brand Devices [Ascension® First Choice® DRUJ System]

• 10381780120773: Ulnar Implant, Head
• 10381780120766: Ulnar Implant, Head
• 10381780120759: Ulnar Implant, Head
• 10381780120742: Ulnar Implant, Head
• 10381780120735: Ulnar Implant, Head
• 10381780120728: Ulnar Implant, Head
• 10381780120711: Ulnar Implant, Head
• 10381780120704: Ulnar Implant, Head
• 10381780120698: Ulnar Implant, Head
• 10381780120681: Ulnar Implant, Head
• 10381780120674: Ulnar Implant, Head
• 10381780120667: Ulnar Implant, Head
• 10381780123651: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123644: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123637: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123620: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123613: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123606: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123590: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123583: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123576: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123569: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123552: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul
• 10381780123545: The Ascensions First Choice DRUJ System is an anatomically designed, semi-constrained, distal ul