Identity
- Trade Name
- Guide Glide II® Guidewire Introducer Needle FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Guide Glide II® Guidewire Introducer Needle One-Wall Style, Pink Plastic Hub, B-Bevel Echogenic Tip, Lubricated, Bevel Indicator 18G (0.12 cm) x 2.75 in. (7.0 cm) Accepts guidewire up to 0.038 in. (0.96 mm) FDA UDI
- Model / Reference
- S01318-2.759LF FDA UDI
- Description
- Guide Glide II® Guidewire Introducer Needle One-Wall Style, Pink Plastic Hub, B-Bevel Echogenic Tip, Lubricated, Bevel Indicator 18G (0.12 cm) x 2.75 in. (7.0 cm) Accepts guidewire up to 0.038 in. (0.96 mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M661S01318275 FDA UDI
- 510(k) Number
- K082580 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1340 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Guide Glide II® Guidewire Introducer Needle by Spectra Medical Devices, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082580 also covers:
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
- Spectra Medical Devices, LLC
Sources (1)
- FDA UDI 750613f7-e8df-4caa-bb4c-bc61f6a4368b 34 fields · synced Jun 9, 2026