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FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ARROW FDA UDI
Generic Name
Intraosseous-access handpiece, infusion, electric FDA UDI
Device Name
EZ-IO(R) Power Driver FDA UDI
Model / Reference
IPN033743 FDA UDI
Description
EZ-IO(R) Power Driver FDA UDI

Identifiers

Catalog Number
9058 FDA UDI
Primary DI / UDI-DI
10816000012465 FDA UDI
510(k) Number
K141117 FDA UDI
FDA Product Code
FMI FDA UDI
GMDN Term
Intraosseous-access handpiece, infusion, electric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI
Sterilization Method
High-level Disinfectant FDA UDI

Category: Intraosseous-access handpiece, infusion, electric

Arrow by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraosseous-access handpiece, infusion, electric.

Cleared under the same submission

K141117 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI 19516765-dd99-41cb-86a0-f0eabf2f8504 37 fields · synced Jun 6, 2026