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Df2

FDA UDI

Class I (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
DF2 FDA UDI
Generic Name
Multiple-joint lower limb orthosis FDA UDI
Device Name
Cool Foam Pad, S FDA UDI
Model / Reference
03-DF2B-0052 FDA UDI
Description
Cool Foam Pad, S FDA UDI

Identifiers

Catalog Number
03-DF2B-0052 FDA UDI
Primary DI / UDI-DI
00840194471817 FDA UDI
FDA Product Code
IQI FDA UDI
GMDN Term
Multiple-joint lower limb orthosis FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Multiple-joint lower limb orthosis

Df2 by Orthopediatrics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-joint lower limb orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI 2d14f4c8-3d88-47bb-ba34-55a169ff9ab2 34 fields · synced May 30, 2026