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 Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral Atherectomy laser system beam guide-catheter, peripheral 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

Devices Manufactured by NORTH EAST SCIENTIFIC INC

• B227NRP1301 - NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter: 2023-09-25
• B227NRP1302 - NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter: 2023-09-25
• B227NRP1303 - NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter: 2023-09-25
• B227NRP3681 - NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter: 2023-09-25
• B227NRP3682 - NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter: 2023-09-25
• B227NRP3683 - NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter: 2023-09-25
• B227NRP3683 - NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter: 2023-09-25
• B227NRP0140 - NES Reprocessed Visions PV .014P RX Digital IVUS Catheter: 2023-07-20
• B227NRP1300 - NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter: 2023-07-20 The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NE