AED HS2950-L Tru-Vu Operative Hystero Sheath, Extended Working Length, 5mm x 21. HS2950-L

GUDID 00848657075138

A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Endoscope sheath, reusable

• Primary Device ID: 00848657075138
• NIH Device Record Key: 84d359d7-c698-4ebd-9b3a-77820899740c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED HS2950-L Tru-Vu Operative Hystero Sheath, Extended Working Length, 5mm x 21.
• Version Model Number: HS2950-L
• Catalog Number: HS2950-L
• 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	00848657075138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141515

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

[00848657075138]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-26
• Device Publish Date: 2023-05-18

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• 00848657076791 - Standard Hystero Grasper, D/A, 3mm x 37cm: 2024-07-10 Standard Hystero Grasper, D/A, 3mm x 37cm