Low Profile Cable BIO-1-1012-A

GUDID B046BIO11012A0

Low Profile Cable

SIGNAL MEDICAL CORPORATION

Internal orthopaedic fixation system, cerclage wire/cable, sterile

• Primary Device ID: B046BIO11012A0
• NIH Device Record Key: 84fe8612-277a-4fd7-97bb-5d5b56d3dc35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Low Profile Cable
• Version Model Number: 1.5mm Cable
• Catalog Number: BIO-1-1012-A
• Company DUNS: 169289308
• Company Name: SIGNAL MEDICAL CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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	B046BIO11012A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951844

FDA Product Code

• JDQ: Cerclage, Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-03
• Device Publish Date: 2021-08-26

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