Identity
- Trade Name
- Dornier MedTech FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- PTFE/Nitinol Guide Wire 0.035", 150cm, Straight 3cm tip, flexible both ends, Super Stiff FDA UDI
- Model / Reference
- Dual Flex with Hydrophilic Tip, Straight, Super Stiff FDA UDI
- Description
- PTFE/Nitinol Guide Wire 0.035", 150cm, Straight 3cm tip, flexible both ends, Super Stiff FDA UDI
Identifiers
- Catalog Number
- MERI3515SS FDA UDI
- Primary DI / UDI-DI
- 00810116021987 FDA UDI
- FDA Product Code
- EYA FDA UDI
- GMDN Term
- Gastro-urological guidewire, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5130 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gastro-urological guidewire, single-use
Dornier MedTech by Dornier MedTech America, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Dornier MedTech America, Inc.
Sources (1)
- FDA UDI 260ab573-153d-4f22-a841-8d7b798847b2 34 fields · synced Jun 9, 2026