Identity
- Trade Name
- MicroEZ Introducer FDA UDI
- Generic Name
- Vascular catheter introduction needle FDA UDI
- Device Name
- 5 F MicroEZ Microintroducer FDA UDI
- Model / Reference
- CK000744 FDA UDI
- Description
- 5 F MicroEZ Microintroducer FDA UDI
Identifiers
- Catalog Number
- CK000744 FDA UDI
- Primary DI / UDI-DI
- 00801741140297 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
- Length — 10 Centimeter FDA UDICatheter Gauge — 5 French FDA UDI
Category: Vascular catheter introduction needle
MicroEZ Introducer by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular catheter introduction needle.
- Cook — COOK INCORPORATED · Class II
- Cook — COOK INCORPORATED · Class II
- Procedure Products Needles — PROCEDURE PRODUCTS, INC. · Class II
- Cook — COOK INCORPORATED · Class II
- ARROW — TELEFLEX INCORPORATED · Class II
- BD Potts-Cournand 18Gx2.05in — BECTON DICKINSON AND COMPANY · Class II
- Procedure Products needles — PROCEDURE PRODUCTS, INC. · Class II
- VASCU-SHEATH® — MEDICAL COMPONENTS 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
- Bard Access Systems, Inc.
Sources (1)
- FDA UDI c4d56949-3895-4978-a951-852c4d79bb9c 36 fields · synced Jun 9, 2026