STORZ (STYLE) CYSTO SHEATH 17FR 32-4070-STZ

GUDID 00848657019132

A component of a rigid endoscope assembly designed as a tube through which an endoscope and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscope sheath, reusable

• Primary Device ID: 00848657019132
• NIH Device Record Key: 3026f5ed-a2f9-4687-befe-3533ba082bea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STORZ (STYLE) CYSTO SHEATH 17FR
• Version Model Number: 32-4070-STZ
• Catalog Number: 32-4070-STZ
• Company DUNS: 839138955
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, 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

Customer Support Contacts

• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md
• Phone: + 8182272720
• Email: customerservice@aed.md

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657019132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993689

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

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

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

[00848657019132]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-02
• Device Publish Date: 2023-04-24

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• 00848657076999 - AED: 2024-07-30 Non-Magnetic Maryland Grasper 5mm x 36cm, Serrated
• 00848657077002 - AED: 2024-07-30 Non-Magnetic Metzenbaum 5mm x 36cm, Curved
• 00848657077019 - AED: 2024-07-30 Precise Lap Bulldog Clamp with diamond dust anti-skid coating, 60mm, Non-Magnetic Version
• 00848657077026 - AED: 2024-07-30 Precise Lap Bulldog Clamp Forcep, 12.5mm x 38cm, Non-Magnetic Version
• 00848657076968 - ENDOPRO-CAM Master Series: 2024-07-23 Endoscopic Video System
• 00848657076791 - Standard Hystero Grasper, D/A, 3mm x 37cm: 2024-07-10 Standard Hystero Grasper, D/A, 3mm x 37cm