LONG IRRIGATION REPLACEMENT MODULE

GUDID 00821925028722

Gyrus Acmi, Inc.

ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system ENT shaver system

• Primary Device ID: 00821925028722
• NIH Device Record Key: 2ecad530-895a-4e8c-8902-53ac36b3d40b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LONG IRRIGATION REPLACEMENT MODULE
• Version Model Number: 70325553
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	00821925028722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992994

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

[00821925028722]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-11

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• 00821925041424 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, TOP LIGHT INSTACLEAR
• 00821925041431 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 45DEG, BOTTOM LIGHT INSTACLEAR
• 00821925041448 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER UNLTRA 70DEG, TOP LIGHT INSTACLEAR
• 00821925041455 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 70DEG, BOTTOM LIGHT INSTACLEAR
• 00810008180983 - nCare: 2023-10-02 nCare, D, DRCT SDI, ELA, DICOM, RCRDG