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Guide Glide II® Guidewire Introducer Needle
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Guide Glide II® Guidewire Introducer Needle FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- 1ga x 2.75", A-Bevel, Clear Plastic Hub, Lubricated, Wing FDA UDI
- Model / Reference
- S01021-2.753L FDA UDI
- Description
- 1ga x 2.75", A-Bevel, Clear Plastic Hub, Lubricated, Wing FDA UDI
Identifiers
- Primary DI / UDI-DI
- M661S010212753 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
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
No
FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Guide Glide II® Guidewire Introducer Needle by Spectra Medical Devices, LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Vascular catheter introduction set, nonimplantable.
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- ARROW — TELEFLEX INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
- Demax — Beijing Demax Medical Technology Co., Ltd · Class II
Cleared under the same submission
K082580 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Spectra Medical Devices, LLC
Sources (2)
- FDA UDI b7d5ebfe-f6f1-4543-a14a-d62b1ad9bd84 34 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 3, 2026