REPAIR EXCHANGE AUTOCLAVABLE SCOPE 4MM 70 DEGREES WIDE.

GUDID 00821925027145

Gyrus Acmi, Inc.

Rigid sinoscope Rigid sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope

• Primary Device ID: 00821925027145
• NIH Device Record Key: 7afa3d85-1fea-49f7-a988-69c8a57c072a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REPAIR EXCHANGE AUTOCLAVABLE SCOPE 4MM 70 DEGREES WIDE.
• Version Model Number: REX70230912
• 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: false
• Serial Number: true
• 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	00821925027145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874215

FDA Product Code

• EOB: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Sterilization

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

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

Moist Heat or Steam Sterilization

[00821925027145]

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