Identity
- Trade Name
- EZ-IO Power Driver EUDAMEDARROW FDA UDI
- Generic Name
- Intraosseous-access handpiece, infusion, electric FDA UDI
- Device Name
- EZ-IO Power Driver EUDAMEDFDA UDI
- Model / Reference
- IPN915667 EUDAMEDFDA UDI9058 EUDAMED
- Description
- EZ-IO Power Driver FDA UDI
Identifiers
- Catalog Number
- 9058 FDA UDI
- Primary DI / UDI-DI
- 10816000013813 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10816000013813 EUDAMED
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A019011 INTRAOSSEOUS INFUSION AND VERTEBROPLASTY INFUSION NEEDLES AND KITS EUDAMED
- GMDN Term
- Intraosseous-access handpiece, infusion, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
High-level Disinfectant FDA UDI
Category: Intraosseous-access handpiece, infusion, electric
Arrow by Teleflex Incorporated — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI e31fedf2-21f5-4bd3-be70-643190bd0a51 36 fields · synced Jun 11, 2026
- EUDAMED 5e49aa3f-c305-42ff-97d3-cb7b600fc853 61 fields · synced Jun 11, 2026