INT, FirstWire
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- INT, FirstWire FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- Guidewire EUDAMED0.035"*180cm, PTFE coating, straight tip FDA UDI
- Model / Reference
- GW352SF EUDAMEDFDA UDI0.018", 0.021", 0.025", 0.028", 0.032", 0.035", 0.038" EUDAMED
- Description
- 0.035"*180cm, PTFE coating, straight tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950900923081 EUDAMEDFDA UDI
- Basic UDI-DI
- 69509009CEAGWMN EUDAMED
- 510(k) Number
- K180177 FDA UDI
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- C04020102 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
- GMDN Term
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Cardiac/peripheral vascular guidewire, single-use
INT, FirstWire by Shanghai Kindly Medical Instruments Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac/peripheral vascular guidewire, single-use.
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Cleared under the same submission
K180177 also covers:
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.
- INT, Denali Guide Wire — Shanghai Kindly Medical Instruments Co., Ltd.
- INT, Falcon Guide Wire — Shanghai Kindly Medical Instruments Co., Ltd.
- INT, Falcon Guide Wire — Shanghai Kindly Medical Instruments Co., Ltd.
- INT, Falcon Guide Wire — Shanghai Kindly Medical Instruments Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Kindly Medical Instruments Co., Ltd.
Sources (2)
- FDA UDI ce0d7b98-c33a-41c1-8a95-a3ff35a3177d 34 fields · synced Oct 5, 2026
- EUDAMED 6edfb31f-e07d-4ccf-afe1-d4709d247de4 61 fields · synced Oct 5, 2026