Identity
- Trade Name
- ZIPwire™ FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Device Name
- Urological guidewire FDA UDI
- Model / Reference
- M0066802280 FDA UDI
- Description
- Urological guidewire FDA UDI
Identifiers
- Catalog Number
- M0066802280 FDA UDI
- Primary DI / UDI-DI
- 00816349011887 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
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 Diameter — 0.038 Inch FDA UDIGuidewire Length — 150 Centimeter FDA UDI
Category: Gastro-urological guidewire, single-use
ZIPwire™ by Lake Region Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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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
- Lake Region Medical Limited
Sources (1)
- FDA UDI 1e475f8b-a80b-446f-8565-6b45f638007d 36 fields · synced May 31, 2026