PCL Retractor BIO-1-1083

GUDID B046BIO110830

PCL Retractor

SIGNAL MEDICAL CORPORATION

Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner Leg procedure positioner

• Primary Device ID: B046BIO110830
• NIH Device Record Key: 3e28449f-d129-4a02-a1e7-fcc83590a5d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCL Retractor
• Version Model Number: N/A
• Catalog Number: BIO-1-1083
• 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
• Phone: 8103647070
• Email: vfowler@signalmd.com
• Phone: 8103647070
• Email: vfowler@signalmd.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B046BIO110830 [Primary]

FDA Product Code

• KIL: Positioner, Socket

Sterilization

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

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

[B046BIO110830]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-01
• Device Publish Date: 2023-02-21

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: 2023-03-01PCL Retractor
• 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