Ascension® First Choice® DRUJ System MUH-600-S45S-WW

GUDID 10381780120711

Ulnar Implant, Head

Ascension Orthopedics, Inc.

Wrist ulna-head prosthesis

• Primary Device ID: 10381780120711
• NIH Device Record Key: fd18b0b3-989c-4b45-a510-265c10576cbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascension® First Choice® DRUJ System
• Version Model Number: MUH600S45SWW
• Catalog Number: MUH-600-S45S-WW
• 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
• 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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780120711 [Primary]
HIBCC	M268MUH600S45SWW1 [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: 4
• Public Version Date: 2021-03-08
• 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