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Donjoy

FDA UDI

Class II (US FDA UDI)

by Djo, Llc

Identity

Trade Name
DONJOY FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system control unit FDA UDI
Device Name
ICEMAN CLASSIC CUBE FDA UDI
Model / Reference
11-0494 FDA UDI
Description
ICEMAN CLASSIC CUBE FDA UDI

Identifiers

Primary DI / UDI-DI
00888912003100 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5720 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circulating-fluid localized thermal therapy system control unit

Donjoy by Djo, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Djo, Llc

Sources (1)

  • FDA UDI 0aec105e-8d69-44f2-b77d-828d51756b67 33 fields · synced Jun 8, 2026