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Maxum

FDA UDI

Class III (US FDA UDI)

by Ototronix, LLC

Identity

Trade Name
MAXUM FDA UDI
Generic Name
Partially-implantable middle ear implant system FDA UDI
Device Name
FORCEPS, ANGLED CYLINDER HOLDING FDA UDI
Model / Reference
M7031 FDA UDI
Description
FORCEPS, ANGLED CYLINDER HOLDING FDA UDI

Identifiers

Primary DI / UDI-DI
M737M70311 FDA UDI
PMA Number
P010023 FDA UDI
FDA Product Code
MPV FDA UDI
GMDN Term
Partially-implantable middle ear implant system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Partially-implantable middle ear implant system

Maxum by Ototronix, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Partially-implantable middle ear implant system.

Cleared under the same submission

P010023 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ototronix, LLC

Sources (1)

  • FDA UDI 44ee5b0c-cb98-4bc0-b3a2-c6a577b45353 34 fields · synced Jun 6, 2026