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AED HS2950-L Tru-Vu Operative Hystero Sheath, Extended Working Length, 5mm x 21.
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AED HS2950-L Tru-Vu Operative Hystero Sheath, Extended Working Length, 5mm x 21. FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- HS2950-L FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- HS2950-L FDA UDI
- Primary DI / UDI-DI
- 00848657075138 FDA UDI
- 510(k) Number
- K141515 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscope sheath, reusable
AED HS2950-L Tru-Vu Operative Hystero Sheath, Extended Working Length, 5mm x 21. by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in…
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Cleared under the same submission
K141515 also covers:
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 84d359d7-c698-4ebd-9b3a-77820899740c 36 fields · synced Jun 1, 2026