Identity
- Trade Name
- Dornier MedTech FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- Nitinol Hydrophilic Guide Wire 0.025", 150cm, Straight, 3cm tip, flexible one end, regular stiffness FDA UDI
- Model / Reference
- Straight, Flexible Tip, Regular FDA UDI
- Description
- Nitinol Hydrophilic Guide Wire 0.025", 150cm, Straight, 3cm tip, flexible one end, regular stiffness FDA UDI
Identifiers
- Catalog Number
- SLIP2515S FDA UDI
- Primary DI / UDI-DI
- 00810116022229 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 6c71e32b-7e53-4197-9f29-681cacd9a6e7 34 fields · synced Jun 9, 2026