CenterCross Ultra LV Catheter

GUDID B094LV01000

The CenterCross Ultra LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vascula

ROXWOOD MEDICAL, INC.

Blunt-microdissection atherectomy catheter

• Primary Device ID: B094LV01000
• NIH Device Record Key: c68d0e6b-e5d6-4e84-8e22-8faf936bfd9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CenterCross Ultra LV Catheter
• Version Model Number: LV-0100
• Company DUNS: 055819211
• Company Name: ROXWOOD MEDICAL, INC.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B094LV01000 [Primary]

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-19

On-Brand Devices [CenterCross Ultra LV Catheter]

• 00858480007060: LV-0100
• B094LV01000: The CenterCross Ultra LV Catheter is intended to be used in conjunction with steerable guidewire