56-25002

GUDID 04546540374004

TEMPORARY CONDYLAR PROSTHESIS, RIGHT

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 04546540374004
• NIH Device Record Key: 943bf04b-89c2-47be-8585-aca725662475
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 56-25002
• Catalog Number: 56-25002
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• 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: 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540374004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133285

FDA Product Code

• NEI: Prosthesis, condyle, mandibular, temporary

Sterilization

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

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

[04546540374004]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

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