UCP Stem 9107-6020-RA

GUDID 04719886894158

UCP Stem broach, #2

UNITED ORTHOPEDIC CORP.

Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach Orthopaedic broach

• Primary Device ID: 04719886894158
• NIH Device Record Key: 0e61e254-7d89-4364-ae8a-3f3f8b12c791
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCP Stem
• Version Model Number: 9107-6020-RA
• Catalog Number: 9107-6020-RA
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• 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: true
• 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: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719886894158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152530

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

[04719886894158]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [UCP Stem]

• 04711605582766: UCP Stem case #2
• 04719886892048: UCP Starter broach
• 04719886891010: UCP Stem broach, #0
• 04719872145370: UCP Starter broach
• 04719886894189: UCP Stem broach, #5
• 04719886894172: UCP Stem broach, #4
• 04719886894165: UCP Stem broach, #3
• 04719886894158: UCP Stem broach, #2
• 04719886894141: UCP Stem broach, #1