Straight Osteotome BIO-1-1093

GUDID B046BIO110930

Straight Osteotome 1/2"

SIGNAL MEDICAL CORPORATION

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"