Olympus

GUDID 00821925042506

SINGLE USE ASPIRATION NEEDLE

Gyrus Acmi, Inc.

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• Primary Device ID: 00821925042506
• NIH Device Record Key: 6bb482aa-eb3f-4f88-beb6-56c0153467db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympus
• Version Model Number: NA-403D-2021
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925042506 [Package]; Contains: 00821925042513; Package: [4 Units]; In Commercial Distribution
GS1	00821925042513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181193

FDA Product Code

• KTI: Bronchoscope accessory

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: 2020-10-01
• Device Publish Date: 2020-09-23

On-Brand Devices [Olympus]

• 00821925043060: SINGLE USE ASPIRATION NEEDLE
• 00821925042506: SINGLE USE ASPIRATION NEEDLE
• 00821925007802: M3 Gold Autoclavable Foroblique Telescope 30°, Color Coded White
• 00821925035836: HIGH SPEED DRILL TUBESET, STANDARD
• 00821925035805: High Speed Drill, Irrigation Clip
• 00821925035652: HIGH SPEED MULTI DRILL STAPES ATTACHMENT
• 00821925035645: HIGH SPEED MULTI DRILL ANGLED LONG ATTACHMENT
• 00821925035638: HIGH SPEED MULTI DRILL STRAIGHT LONG ATTACHMENT
• 00821925035621: HIGH SPEED MULTI DRILL ANGLED SHORT ATTACHMENT
• 00821925035614: HIGH SPEED MULTI DRILL STRAIGHT SHORT ATTACHMENT
• 00821925035607: High Speed Multi Drill Hand Piece / Otology
• 00821925044524: POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
• 00821925044562: POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION
• 00821925044548: POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION