Identity
- Trade Name
- Guide Glide Guidewire Introducer Needle FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- Intro Needle, 21ga x 7cm FDA UDI
- Model / Reference
- 0720658 FDA UDI
- Description
- Intro Needle, 21ga x 7cm FDA UDI
Identifiers
- Catalog Number
- 0720658 FDA UDI
- Primary DI / UDI-DI
- 00801741086878 FDA UDI
- 510(k) Number
- K082580 FDA UDI
- FDA Product Code
- DYB FDA UDI
- GMDN Term
- Vascular catheter introduction needle 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
Dimensions & Sizes
- Size
- Needle Gauge — 21 Gauge FDA UDILength — 70 Millimeter FDA UDI
Category: Vascular catheter introduction needle
Guide Glide Guidewire Introducer Needle by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082580 also covers:
- Guide Glide II® Guidewire Introducer Needle — Spectra Medical Devices, LLC
- Guide Glide II® Guidewire Introducer Needle — Spectra Medical Devices, LLC
- Guidewire Introducer Needle — Spectra Medical Devices, LLC
- VYGON — Vygon Corp.
- VYGON — Vygon Corp.
- VYGON — Vygon Corp.
- VYGON — Vygon Corp.
- VYGON — Vygon Corp.
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
- Bard Access Systems, Inc.
Sources (1)
- FDA UDI 2c88012b-23a8-43a7-b124-c17f95742396 37 fields · synced Jun 9, 2026