VACURETTE "F" SET 7MM 10/PKG

GUDID 00821925004481

Gyrus Acmi, Inc.

Intrauterine curette, suction

• Primary Device ID: 00821925004481
• NIH Device Record Key: c3d2fa74-0f40-4681-970d-3592aed4d8ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VACURETTE "F" SET 7MM 10/PKG
• Version Model Number: 23157
• 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	00821925004481 [Package]; Contains: 00821925042230; Package: [10 Units]; In Commercial Distribution
GS1	00821925042230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030935
• Premarket Notification: K171440

FDA Product Code

• HHI: SYSTEM, ABORTION, VACUUM
• HHK: Curette, Suction, Endometrial (And Accessories)

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: 2016-09-30

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