NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter R-414-159

GUDID B227NRP1301

NORTH EAST SCIENTIFIC INC

Atherectomy laser system beam guide-catheter, peripheral

• Primary Device ID: B227NRP1301
• NIH Device Record Key: 0220357b-04a5-4bcf-9d18-d00ae2db3bd8
• Commercial Distribution Discontinuation: 2030-11-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter
• Version Model Number: R-414-159
• Catalog Number: R-414-159
• Company DUNS: 608625823
• Company Name: NORTH EAST SCIENTIFIC INC
• Device Count: 1
• DM Exempt: true
• 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: 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	B227NRP1301 [Primary]

FDA Product Code

• QTF: Reprocessed Atherectomy Catheter

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: 2023-09-25
• Device Publish Date: 2023-09-15

On-Brand Devices [NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter]

• B227NRP1301: R-414-159
• 00850044399123: R-414-159