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Ponto

FDA UDI

Class II (US FDA UDI)

by Oticon Medical

Identity

Trade Name
Ponto FDA UDI
Generic Name
Anchored bone-conduction hearing implant system FDA UDI
Device Name
Ponto 3 SuperPower, R, MBR FDA UDI
Model / Reference
M52651 FDA UDI
Description
Ponto 3 SuperPower, R, MBR FDA UDI

Identifiers

Catalog Number
M52651 FDA UDI
Primary DI / UDI-DI
05712149011858 FDA UDI
FDA Product Code
LXB FDA UDI
GMDN Term
Anchored bone-conduction hearing implant system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3302 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Anchored bone-conduction hearing implant system

Ponto by Oticon Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anchored bone-conduction hearing implant system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oticon Medical

Sources (1)

  • FDA UDI a43b2e2f-6031-45d6-8a1c-ebf0f60313cc 35 fields · synced May 31, 2026