Identity
- Trade Name
- Endobronchial Tube FDA UDI
- Generic Name
- Endobronchial tube FDA UDI
- Device Name
- right Fr41 FDA UDI
- Model / Reference
- A03A024110 FDA UDI
- Description
- right Fr41 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944932759404 FDA UDI
- 510(k) Number
- K092886 FDA UDI
- FDA Product Code
- CBI FDA UDI
- GMDN Term
- Endobronchial tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endobronchial tube
Endobronchial Tube by Well Lead Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endobronchial tube.
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- Mallinckrodt — Covidien LP · Class II
- SILBRONCHO (RIGHT LUNG) — Fuji Systems Corp. · Class II
Cleared under the same submission
K092886 also covers:
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (1)
- FDA UDI 991d859b-587c-43b9-8b32-34769bd92d5e 34 fields · synced May 30, 2026