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Freddo

FDA UDI

Class II (US FDA UDI)

by Fabinject Llc

Identity

Trade Name
FREDDO FDA UDI
Generic Name
Localized cutaneous/musculoskeletal cryotherapy unit FDA UDI
Device Name
Skin cooling device FDA UDI
Model / Reference
056/24-3210 FDA UDI
Description
Skin cooling device FDA UDI

Identifiers

Primary DI / UDI-DI
00850064466027 FDA UDI
510(k) Number
K242132 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Localized cutaneous/musculoskeletal cryotherapy unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Localized cutaneous/musculoskeletal cryotherapy unit

Freddo by Fabinject Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Localized cutaneous/musculoskeletal cryotherapy unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fabinject Llc

Sources (1)

  • FDA UDI bc5328c6-4330-4981-ac78-0da799398605 36 fields · synced May 30, 2026