Identity
- Trade Name
- MedSource Stylet, Individually Packaged, 12FR FDA UDI
- Generic Name
- Artificial airway stylet, single-use FDA UDI
- Device Name
- Stylet, Individually Packaged, 12FR FDA UDI
- Model / Reference
- MS-ETS300 FDA UDI
- Description
- Stylet, Individually Packaged, 12FR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816703020463 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Artificial airway stylet, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 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
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Category: Artificial airway stylet, single-use
MedSource Stylet, Individually Packaged, 12FR by Medsource International Llc — 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
- Medsource International Llc
Sources (1)
- FDA UDI cd4d614d-528b-4b4c-bfc6-5a4f37dc83f8 33 fields · synced May 31, 2026