NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter R-420-006

GUDID B227NRP3683

NORTH EAST SCIENTIFIC INC

Atherectomy laser system beam guide-catheter, peripheral

• Primary Device ID: B227NRP3683
• NIH Device Record Key: eb9e3f34-df6b-4180-9288-9215b15f053a
• Commercial Distribution Discontinuation: 2030-11-24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter
• Version Model Number: R-420-006
• Catalog Number: R-420-006
• 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: false
• 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	B227NRP3683 [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 2.0mm OTW Turbo Elite Laser Atherectomy Catheter]

• B227NRP3683: R-420-006
• 00850044399079: R-420-006