Identity
- Trade Name
- wellead FDA UDI
- Generic Name
- Cricothyrotomy kit, single-use FDA UDI
- Device Name
- Cricothyrotomy kit, Type I, Cuffed, 6.0mm DEHP FREE (Sterile) FDA UDI
- Model / Reference
- 10-0048 FDA UDI
- Description
- Cricothyrotomy kit, Type I, Cuffed, 6.0mm DEHP FREE (Sterile) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944932791879 FDA UDI
- FDA Product Code
- OGP FDA UDI
- GMDN Term
- Cricothyrotomy kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cricothyrotomy kit, single-use
wellead by Well Lead Medical Co., Ltd — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (1)
- FDA UDI 05a21fb6-0f5c-47a8-8401-15f0bad9bd37 33 fields · synced Jun 6, 2026