Curved Osteotome BIO-1-1095

GUDID B046BIO110950

Curved Osteotome 1/2"

SIGNAL MEDICAL CORPORATION

Orthopaedic osteotome

• Primary Device ID: B046BIO110950
• NIH Device Record Key: 41a7d260-641e-46a0-b1b4-2f421ea323ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curved Osteotome
• Version Model Number: 1/2"
• Catalog Number: BIO-1-1095
• 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	B046BIO110950 [Primary]

FDA Product Code

• GFI: Osteotome, Manual

Sterilization

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

[B046BIO110950]

Moist Heat or Steam Sterilization

[B046BIO110950]

Moist Heat or Steam Sterilization

[B046BIO110950]

Moist Heat or Steam Sterilization

[B046BIO110950]

Moist Heat or Steam Sterilization

[B046BIO110950]

Moist Heat or Steam Sterilization

[B046BIO110950]

Moist Heat or Steam Sterilization

[B046BIO110950]

Moist Heat or Steam Sterilization

[B046BIO110950]

Moist Heat or Steam Sterilization

[B046BIO110950]

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

Devices Manufactured by SIGNAL MEDICAL CORPORATION

• B046BIO110930 - Straight Osteotome: 2023-05-02 Straight Osteotome 1/2"
• B046BIO110440 - Knee Osteogator: 2023-03-22 Knee Osteogator
• B046BIO110830 - PCL Retractor: 2023-03-01 PCL Retractor
• B046BIO11081 - Femoral Belt: 2022-06-27 Femoral Belt
• B046BIO110430 - Alligator Rongeur: 2022-05-20 9" Alligator Rongeur
• B046BIO11082 - Tibial Belt: 2022-05-20 Tibial Belt
• B046BIO110840 - Lateral Retractor: 2022-05-20 Lateral Retractor
• B046BIO110910 - Mallet Tip - Teflon: 2022-04-01 Mallet Tip - Teflon