PolypVac® FG-000017

GUDID 00862519000328

LAURIMED, LLC

ENT shaver system handpiece

• Primary Device ID: 00862519000328
• NIH Device Record Key: 00db9859-c529-4023-8887-2d7fad91a443
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolypVac®
• Version Model Number: 4.0mm Microdebrider
• Catalog Number: FG-000017
• Company DUNS: 622446255
• Company Name: LAURIMED, LLC
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862519000328 [Primary]
GS1	00862519000335 [Package]; Package: Box [4 Units]; In Commercial Distribution

FDA Product Code

• ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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: 2016-10-10

On-Brand Devices [PolypVac®]

• 00862519000328: 4.0mm Microdebrider
• 00862519000304: 3.3mm Microdebrider