REUNION 5901-M-4815

GUDID 07613327603255

Modular Humeral Head Trial

Stryker Trauma SA

Humeral head prosthesis trial, reusable

• Primary Device ID: 07613327603255
• NIH Device Record Key: 793e1a22-5504-452b-a543-668a8666938b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REUNION
• Version Model Number: 5901-M-4815
• Catalog Number: 5901-M-4815
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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

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
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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
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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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327603255 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

[07613327603255]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-09
• Device Publish Date: 2024-10-01

On-Brand Devices [REUNION]

• 07613327466195: Shoulder Case
• 07613327465556: Shoulder Insert
• 07613327425383: Humeral Reamer (13mm)
• 07613327425376: Cemented Humeral Stem
• 07613327425369: Press-fit Humeral Stem
• 07613327425352: Humeral Reamer (12mm)
• 07613327425345: Humeral Reamer (19mm)
• 07613327425338: Humeral Calcar Planar (Medium)
• 07613327425321: Humeral Reamer (18mm)
• 07613327425314: Cemented Humeral Stem
• 07613327425291: Humeral Reamer (10mm)
• 07613327425284: Cemented Humeral Stem
• 07613327425277: Humeral Broach (9mm)
• 07613327425260: Humeral Reamer (11mm)
• 07613327425246: Humeral Broach (8mm)
• 07613327425239: Humeral Reamer (9mm)
• 07613327425222: Cemented Humeral Stem
• 07613327425215: Humeral Assembly Block (Upper Deck)
• 07613327425208: Cemented Humeral Stem
• 07613327425192: Press-fit Humeral Stem
• 07613327425185: Humeral Assembly Block (Lower Deck)
• 07613327425178: Humeral Broach (10mm)
• 07613327425161: Humeral Reamer (20mm)
• 07613327425154: Humeral Reamer (7mm)
• 07613327425147: Humeral Broach (7mm)
• 07613327425130: Humeral Broach (16mm)
• 07613327425123: Humeral Protector Plate (Small)
• 07613327425116: Humeral Protector Plate (Large)
• 07613327425109: Cemented Humeral Stem
• 07613327425093: Humeral Reamer (8mm)
• 07613327425086: Press-fit Humeral Stem
• 07613327425079: Humeral Broach (12mm)
• 07613327425062: Press-fit Humeral Stem
• 07613327425055: Cemented Humeral Stem
• 07613327425048: Humeral Broach (11mm)
• 07613327425031: Humeral Broach (13mm)
• 07613327425024: Starter Awl
• 07613327425017: Press-fit Humeral Stem
• 07613327425000: Press-fit Humeral Stem
• 07613327424997: Humeral Reamer (14mm)
• 07613327424980: Humeral Protector Plate (Medium)
• 07613327424973: Press-fit Humeral Stem
• 07613327424966: Humeral Broach (20mm)
• 07613327424959: Cemented Humeral Stem
• 07613327424942: Humeral Broach (19mm)
• 07613327424935: Cemented Humeral Stem
• 07613327424928: Press-fit Humeral Stem
• 07613327424911: Cemented Humeral Stem
• 07613327424904: Press-fit Humeral Stem
• 07613327424898: Cemented Humeral Stem