Identity
- Trade Name
- SPECTRE FDA UDI
- Generic Name
- Cardiac/peripheral vascular guidewire, single-use FDA UDI
- Device Name
- Spectre Guidewire, 300cm FDA UDI
- Model / Reference
- IPN916606 FDA UDI
- Description
- Spectre Guidewire, 300cm FDA UDI
Identifiers
- Catalog Number
- 7387 FDA UDI
- Primary DI / UDI-DI
- 10841156108021 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
Yes
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 — 300 Centimeter FDA UDI
Category: Cardiac/peripheral vascular guidewire, single-use
Spectre by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac/peripheral vascular guidewire, single-use.
- INT, FirstWire — Shanghai Kindly Medical Instruments Co., Ltd. · Class II
- Urological Guide Wire — Well Lead Medical Co., Ltd · Class II
- ProVia 3 — MEDTRONIC, INC. · Class II
- Mighty Wire™ — Merit Medical Systems, Inc. · Class II
- Forté™ — Lake Region Medical · Class II
- Confida™ — MEDTRONIC, INC. · Class II
- ASAHI CHIKAI X 014 soft — ASAHI INTECC CO., LTD. · Class II
- ZINGER® MEDIUM — MEDTRONIC, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (1)
- FDA UDI 5bbf54fa-cbbb-4d6c-b87a-d9bc38e13d5f 36 fields · synced May 31, 2026