USA Series™ Office Diagnostic Hysteroscope Sheath 5 mm (15 Fr)

GUDID 00821925002524

GYD15 Single Flow Hys-Sheath 5mm for M3

Gyrus Acmi, Inc.

Rigid optical hysteroscope

• Primary Device ID: 00821925002524
• NIH Device Record Key: d8471bb1-3517-4a17-8ab9-e6241dd39701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USA Series™ Office Diagnostic Hysteroscope Sheath 5 mm (15 Fr)
• Version Model Number: GYD15
• 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	00821925002524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890328

FDA Product Code

• FAS: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

[00821925002524]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-14

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