Straight Osteotome BIO-1-1093

GUDID B046BIO110930

Straight Osteotome 1/2"

SIGNAL MEDICAL CORPORATION

Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome

• Primary Device ID: B046BIO110930
• NIH Device Record Key: f3476cf4-ca52-4308-bbd2-8cb11309bbc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straight Osteotome
• Version Model Number: 1/2"
• Catalog Number: BIO-1-1093
• Company DUNS: 169289308
• Company Name: SIGNAL MEDICAL CORPORATION
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B046BIO110930 [Primary]

FDA Product Code

• GFI: Osteotome, Manual

Sterilization

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

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

[B046BIO110930]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-02
• Device Publish Date: 2023-04-24

On-Brand Devices [Straight Osteotome]

• B046BIO110920: Straight Osteotome 1/4"
• B046BIO110930: Straight Osteotome 1/2"