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Spectra Guidewire Introducer Needle
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref S01321-2.759LF
Identity
- Trade Name
- Guide Glide II® Guidewire Introducer Needle FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Spectra Guidewire Introducer Needle EUDAMEDGuide Glide II® Guidewire Introducer Needle One-Wall Style, Green Plastic Hub, B-Bevel Echogenic Tip, Lubricated, Bevel Indicator 21G (0.08 cm) x 2.75 in. (7.0 cm) Accepts guidewire up to 0.021 in. (0.53 mm) FDA UDI
- Model / Reference
- S01321-2.759LF EUDAMEDFDA UDI
- Description
- Guide Glide II® Guidewire Introducer Needle One-Wall Style, Green Plastic Hub, B-Bevel Echogenic Tip, Lubricated, Bevel Indicator 21G (0.08 cm) x 2.75 in. (7.0 cm) Accepts guidewire up to 0.021 in. (0.53 mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- +M661S013212759LFV EUDAMEDM661S01321275 FDA UDI
- Basic UDI-DI
- ++M661Introducer2AAF EUDAMED
- 510(k) Number
- K082580 FDA UDI
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Spectra Guidewire Introducer Needle by Spectra Medical Devices, LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082580 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++M661Introducer2AAF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Spectra Medical Devices, LLC
- EUDAMED SRN
- US-MF-000008491
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (3)
- EUDAMED 5283231c-8ce4-4b28-8f1c-a2d3f43d89b8 61 fields · synced Jul 9, 2026
- FDA UDI 80c3e081-2f47-45a2-97ae-36a2107ba8e7 34 fields · synced May 30, 2026
- FDA 510(k) K082580 1 fields · synced May 18, 2026