STORZ (STYLE) CYSTO SHEATH 19FR 32-4075-STZ

GUDID 00848657019156

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 Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable Endoscope sheath, reusable

• Primary Device ID: 00848657019156
• NIH Device Record Key: de3b3d25-d948-4995-ba65-485432567d2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STORZ (STYLE) CYSTO SHEATH 19FR
• Version Model Number: 32-4075-STZ
• Catalog Number: 32-4075-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	00848657019156 [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

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

Moist Heat or Steam Sterilization

[00848657019156]

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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• 00848657076814 - Curved Metz Scissor, D/A, Rotating, 3mm x 37cm: 2024-07-10 A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp
• 00848657076821 - Large Biopsy Cup Forcep, D/A, 3mm x 37cm: 2024-07-10 A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastr
• 00848657076920 - ENDOPRO-CAM Master Series: 2024-06-19 Endoscopic Video System
• 00848657076937 - ENDOPRO-MDTK: 2024-06-19 Monostereo 3D Video System Enhancement
• 00848657023108 - AED Power Bank Battery, Rechargeable: 2023-10-20 AED Power Bank Battery, Rechargeable
• 00848657068796 - Retractor: 2023-10-20 A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision t