Olympus

GUDID 00821925035836

HIGH SPEED DRILL TUBESET, STANDARD

Gyrus Acmi, Inc.

Surgical irrigation/aspiration tubing set

• Primary Device ID: 00821925035836
• NIH Device Record Key: 565e4932-2166-4f65-a635-fe66fc84e2a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympus
• Version Model Number: TS200S
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925035812 [Primary]
GS1	00821925035836 [Package]; Contains: 00821925035812; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152744

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-26
• Device Publish Date: 2021-04-16

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
• 00821925045132: POWERSEAL 5 MM, 44 CM, STRAIGHT JAW SEALER & DIVIDER, DOUBLE-ACTION (5/PK)
• 00821925043817: LITHOTRIPSY PROBE, REUSABLE, ShockPulse-SE 11.3 Fr (3.76 mm) x 396 mm
• 00821925045125: POWERSEAL 5 MM, 37 CM, STRAIGHT JAW SEALER & DIVIDER, DOUBLE-ACTION (5/PK)
• 00821925045118: POWERSEAL 5 MM, 23 CM, STRAIGHT JAW SEALER & DIVIDER, DOUBLE-ACTION (5/PK)
• 00821925045071: POWERSEAL 5 MM, 44 CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION (5/PK)
• 00821925045064: POWERSEAL 5 MM, 37 CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION (5/PK)
• 00821925045057: POWERSEAL 5 MM, 23 CM, CURVED JAW SEALER & DIVIDER, SINGLE-ACTION (5/PK)