Flexible Osteotome System with Radel Case 2709-04-000; 30-005-000-1500

GUDID 00847538015256

Flexible Osteotome System with Radel Case

SYMMETRY MEDICAL INC.

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00847538015256
• NIH Device Record Key: 5ea7b364-962d-4de9-a38d-3d2c8dbb3cc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Osteotome System with Radel Case
• Version Model Number: 30-005-000
• Catalog Number: 2709-04-000; 30-005-000-1500
• Company DUNS: 079881212
• Company Name: SYMMETRY MEDICAL 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847538015256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012105

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

[00847538015256]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-25
• Device Publish Date: 2023-07-17

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• 00847538009316 - Medium Radial Osteotome Blade: 2023-10-02 Medium Radial Osteotome Blade
• 00847538009354 - Long Flat Osteotome Blade: 2023-10-02 Long Flat Osteotome Blade
• 00847538009378 - Medium Flat Osteotome Blade: 2023-10-02 Medium Flat Osteotome Blade
• 00847538018721 - GLOBAL UNITE™ Short Stem Instrumentation: 2023-09-13 SHORT BULLET TIP REAMER 8MM
• 00847538018738 - GLOBAL UNITE™ Short Stem Instrumentation: 2023-09-13 SHORT BULLET TIP REAMER 10MM