Straight Osteotome BIO-1-1092

GUDID B046BIO110920

Straight Osteotome 1/4"

SIGNAL MEDICAL CORPORATION

Orthopaedic osteotome

• Primary Device ID: B046BIO110920
• NIH Device Record Key: ab3500b1-07ce-44d1-834b-fa65645ce62f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straight Osteotome
• Version Model Number: 1/4"
• Catalog Number: BIO-1-1092
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B046BIO110920 [Primary]

FDA Product Code

• GFI: Osteotome, Manual

Sterilization

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

[B046BIO110920]

Moist Heat or Steam Sterilization

[B046BIO110920]

Moist Heat or Steam Sterilization

[B046BIO110920]

Moist Heat or Steam Sterilization

[B046BIO110920]

Moist Heat or Steam Sterilization

[B046BIO110920]

Moist Heat or Steam Sterilization

[B046BIO110920]

Moist Heat or Steam Sterilization

[B046BIO110920]

Moist Heat or Steam Sterilization

[B046BIO110920]

Moist Heat or Steam Sterilization

[B046BIO110920]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-19
• Device Publish Date: 2021-08-11

On-Brand Devices [Straight Osteotome]

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