Identity
- Trade Name
- INT,PV3-G FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- 18 PV-3 x 300 cm FDA UDI
- Model / Reference
- PGW1803SSF FDA UDI
- Description
- 18 PV-3 x 300 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950900906893 FDA UDI
- 510(k) Number
- K180177 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiac/peripheral vascular guidewire, single-use
Int, Pv3-G by Shanghai Kindly Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (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
- Shanghai Kindly Medical Instruments Co., Ltd.
Sources (1)
- FDA UDI 1f4b6e62-1616-463c-a077-87908fde68c7 34 fields · synced May 30, 2026