ACMI Seal Self Sealing For Accessories up to 7 FR (2.33 mm)

GUDID 00821925001220

Gyrus Acmi, Inc.

Endoscopic biopsy valve, sterile

• Primary Device ID: 00821925001220
• NIH Device Record Key: 5dc57484-a9b9-4251-b7cb-1f212082aaeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACMI Seal Self Sealing For Accessories up to 7 FR (2.33 mm)
• Version Model Number: CS-W7S
• 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	00821925001220 [Package]; Contains: 00821925036352; Package: [6 Units]; In Commercial Distribution
GS1	00821925036352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012758

FDA Product Code

• FGB: Ureteroscope and accessories, flexible/rigid

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: 2016-10-13

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