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Oncontrol

FDA UDI

Class II (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name
ONCONTROL FDA UDI
Generic Name
Intraosseous-access handpiece, infusion, electric FDA UDI
Device Name
OnControl® Power Driver FDA UDI
Model / Reference
IPN919011 FDA UDI
Description
OnControl® Power Driver FDA UDI

Identifiers

Catalog Number
9401 FDA UDI
Primary DI / UDI-DI
10841156108434 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Intraosseous-access handpiece, infusion, electric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1075 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

Yes

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
MRI Safety
MR Unsafe FDA UDI

Category: Intraosseous-access handpiece, infusion, electric

Oncontrol 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teleflex Incorporated

Sources (1)

  • FDA UDI e687e75b-2e66-45a1-bb28-7391851176e0 35 fields · synced Jun 1, 2026