Identity
- Trade Name
- Key Surgical Guidewire FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- Hydrophilic Guidewire, Zebra-Coated, Straight Tip, 0.035-inch Diam, 2600mm L FDA UDI
- Model / Reference
- EN10452B FDA UDI
- Description
- Hydrophilic Guidewire, Zebra-Coated, Straight Tip, 0.035-inch Diam, 2600mm L FDA UDI
Identifiers
- Catalog Number
- EN10452B FDA UDI
- Primary DI / UDI-DI
- 00849771039310 FDA UDI
- FDA Product Code
- OCY FDA UDI
- GMDN Term
- Gastro-urological guidewire, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Guidewire Length — 2600 Millimeter FDA UDIGuidewire Diameter — 0.035 Inch FDA UDI
Key Surgical Guidewire by Key Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Key Surgical, LLC
Sources (1)
- FDA UDI 62367545-d3be-4adf-8440-af33982cb997 38 fields · synced May 30, 2026