Identity
- Trade Name
- Novo Surgical FDA UDI
- Generic Name
- Tracheal surgery dilator, reusable FDA UDI
- Device Name
- zenith trosseu tracheal dilator, dual-bladed, curved, adult, 5-1/2" (14.0 cm) FDA UDI
- Model / Reference
- E98477-13 FDA UDI
- Description
- zenith trosseu tracheal dilator, dual-bladed, curved, adult, 5-1/2" (14.0 cm) FDA UDI
Identifiers
- Catalog Number
- E98477-13 FDA UDI
- Primary DI / UDI-DI
- G586E98477130 FDA UDI
- FDA Product Code
- KCG FDA UDI
- GMDN Term
- Tracheal surgery dilator, reusable 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Tracheal surgery dilator, reusable
Novo Surgical by Novo Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 5041e057-e915-480e-97d6-8e9a0204e0a7 35 fields · synced Jun 6, 2026