Identity
- Trade Name
- TONN™ NOVATECH® FDA UDI
- Generic Name
- Endotracheal tube introducer, reusable FDA UDI
- Device Name
- TONN™ NOVATECH® EUDAMEDStent Applicator, red FDA UDI
- Model / Reference
- 02BRSR130 EUDAMEDFDA UDI
- Description
- Stent Applicator, red FDA UDI
Identifiers
- Catalog Number
- 02BRSR130 FDA UDI
- Primary DI / UDI-DI
- 14063108105599 EUDAMEDFDA UDI
- Basic UDI-DI
- 4063108TONBN EUDAMED
- Direct Marketing DI
- 14063108105599 EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- P0480 RESPIRATORY PROSTHESES - ACCESSORIES EUDAMED
- GMDN Term
- Endotracheal tube introducer, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Tonn™ Novatech® by Novatech Sa — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4063108TONBN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Novatech Sa
- EUDAMED SRN
- FR-MF-000001658
Sources (2)
- EUDAMED fa2ab923-3e6c-442a-83ef-34b00cbcf0b8 61 fields · synced Jul 9, 2026
- FDA UDI 8e8d3508-e045-493d-aa47-ab3f41f3725f 34 fields · synced May 30, 2026