Adjustable Biopsy Port Seal

GUDID 00821925027312

Gyrus Acmi, Inc.

Endoscopic biopsy valve, sterile Endoscopic biopsy valve, sterile Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope Rigid optical ureteroscope

• Primary Device ID: 00821925027312
• NIH Device Record Key: 15d7af14-854d-44c1-a857-c6542c3121ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adjustable Biopsy Port Seal
• Version Model Number: BPS-A
• 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	00821925027312 [Package]; Contains: 00821925031500; Package: [5 Units]; In Commercial Distribution
GS1	00821925031500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012929

FDA Product Code

• FAJ: Cystoscope 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: 6
• Public Version Date: 2019-07-09
• Device Publish Date: 2016-10-13

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