Identity
- Trade Name
- AED FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- STORZ MOUNT ARTHROSCOPY SHEATH, 4MM, DOUBLE VALVE ROTATING FDA UDI
- Model / Reference
- SZ1770 FDA UDI
- Description
- STORZ MOUNT ARTHROSCOPY SHEATH, 4MM, DOUBLE VALVE ROTATING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848657074575 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endoscope sheath, reusable
Aed by National Advanced Endoscopy Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope sheath, reusable.
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- B.I.O.H. — Karl Storz GmbH & Co. KG · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- SpineTIP — Karl Storz GmbH & Co. KG · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
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 I | Pending data |
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Manufacturer
- Manufacturer
- National Advanced Endoscopy Devices, Inc.
Sources (1)
- FDA UDI 490a7b11-9b74-4573-87e4-9538489cee66 33 fields · synced Jun 8, 2026