Identity
- Trade Name
- MR Cannula FDA UDI
- Generic Name
- Catheter stylet FDA UDI
- Model / Reference
- 4013-05 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17340007000475 FDA UDI
- FDA Product Code
- GEA FDA UDI
- GMDN Term
- Catheter stylet FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
MR Safe FDA UDI
Category: Catheter stylet
MR Cannula by Clinical Laserthermia Systems AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Stylet — APPLIED MEDICAL RESOURCES CORP. · Class II
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
- Clinical Laserthermia Systems AB
Sources (1)
- FDA UDI 7432cc39-79f8-4acf-baae-d43d8fb6c818 33 fields · synced May 30, 2026