USA Elite System™ M3™ Autoclavable Retrograde Telescope 110°, Color C

GUDID 00821925005655

M3-110A M3-110 AUTOCLAVABLE TELESCOPE

Gyrus Acmi, Inc.

Rigid endoscope telescope

• Primary Device ID: 00821925005655
• NIH Device Record Key: ca2d10e3-b936-4e7f-bee6-403aa6994d96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Elite System™ M3™ Autoclavable Retrograde Telescope 110°, Color C
• Version Model Number: M3-110A
• 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	00821925005655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• FAS: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Sterilization

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

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

Moist Heat or Steam Sterilization

[00821925005655]

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: 2016-10-14

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