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Myo Plus trial kit

FDA UDI

Class II (US FDA UDI)

by Otto Bock Healthcare Products GmbH

Identity

Trade Name
Myo Plus trial kit FDA UDI
Generic Name
Myoelectric hand prosthesis FDA UDI
Model / Reference
642V64=T-PLUS-OB FDA UDI

Identifiers

Primary DI / UDI-DI
04064411245340 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Myoelectric hand prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Myoelectric hand prosthesis

Myo Plus trial kit by Otto Bock Healthcare Products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Myoelectric hand prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Otto Bock Healthcare Products GmbH

Sources (1)

  • FDA UDI 65d4e7f7-5e7b-4ec0-a22b-4bd3a7f583e1 32 fields · synced Jun 8, 2026