Identity
- Trade Name
- Novo Surgical Inc. FDA UDI
- Generic Name
- ENT examination/treatment system FDA UDI
- Device Name
- laryngeal mirror, octagon handle, 8" (20.3 cm), size 5, 20.0 mm FDA UDI
- Model / Reference
- E8459-31 FDA UDI
- Description
- laryngeal mirror, octagon handle, 8" (20.3 cm), size 5, 20.0 mm FDA UDI
Identifiers
- Catalog Number
- E8459-31 FDA UDI
- Primary DI / UDI-DI
- 00842331128103 FDA UDI
- FDA Product Code
- KAI FDA UDI
- GMDN Term
- ENT examination/treatment system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: ENT examination/treatment system
Novo Surgical Inc.'s Novo Surgical Laryngeal Mirror is a high-quality, single-use device designed for ENT examination and treatment. With its octagon handle, 8-inch (20.3 cm) size, and 5mm opening, this mirror provides precise visualization for surgeons and medical professionals.
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Also classified as ENT examination/treatment system.
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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
- Novo Surgical, Inc.
Sources (1)
- FDA UDI 8d8d0c98-859b-4a74-85ae-bd085a018af6 35 fields · synced Jul 6, 2026