Identity
- Trade Name
- ATTAIN HYBRID™ Guide Wire FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- GUIDE WIRE GWR419478 98CM GLOBAL CE FDA UDI
- Model / Reference
- GWR419478 FDA UDI
- Description
- GUIDE WIRE GWR419478 98CM GLOBAL CE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169452442 FDA UDI
- 510(k) Number
- K143316 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 98.0 Centimeter FDA UDIOuter Diameter — 0.356 Millimeter FDA UDI
Category: Cardiac/peripheral vascular guidewire, single-use
ATTAIN HYBRID™ Guide Wire by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac/peripheral vascular guidewire, single-use.
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- JUDO™ 1 — Boston Scientific · Class II
Cleared under the same submission
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
- Medtronic, Inc.
Sources (1)
- FDA UDI 387c8838-9144-430d-a8e6-0401a3e19164 37 fields · synced Jun 6, 2026