Dolphin Collection kit

GUDID 00821925000322

Gyrus Acmi, Inc.

Hysteroscopic insufflator

• Primary Device ID: 00821925000322
• NIH Device Record Key: 65319a44-4483-4cf6-9b49-daebe605c0a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dolphin Collection kit
• Version Model Number: 006775-901
• 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	00821925000322 [Package]; Contains: 00821925030947; Package: [5 Units]; In Commercial Distribution
GS1	00821925030947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941743

FDA Product Code

• HHK: Curette, Suction, Endometrial (And Accessories)
• HIG: INSUFFLATOR, HYSTEROSCOPIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-07

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