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Softzone Low Profile Fabric Covered Insole, Small, Pair

FDA UDI

Class I (US FDA UDI)

by SILIPOS Holding LLC

Identity

Trade Name
Softzone Low Profile Fabric Covered Insole, Small, Pair FDA UDI
Generic Name
Orthotic insole, prefabricated, antimicrobial FDA UDI
Model / Reference
4030 FDA UDI

Identifiers

Primary DI / UDI-DI
00614464040306 FDA UDI
FDA Product Code
KYS FDA UDI
GMDN Term
Orthotic insole, prefabricated, antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6280 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: Orthotic insole, prefabricated, antimicrobial

Softzone Low Profile Fabric Covered Insole, Small, Pair by SILIPOS Holding LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthotic insole, prefabricated, antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SILIPOS Holding LLC

Sources (1)

  • FDA UDI 2467926d-f06b-4307-88f4-269dbdb9767e 32 fields · synced Jun 8, 2026