← Back to catalogue

DARCO® Peg-Assist™ Off-loading Insole

FDA UDI

Class I (US FDA UDI)

by DARCO International, Inc.

Identity

Trade Name
DARCO® Peg-Assist™ Off-loading Insole FDA UDI
Generic Name
Pressure-management insole, prefabricated FDA UDI
Device Name
Men's extra-large Blue Square-toe, 7-size FDA UDI
Model / Reference
PTQM4 FDA UDI
Description
Men's extra-large Blue Square-toe, 7-size FDA UDI

Identifiers

Catalog Number
PTQM4 FDA UDI
Primary DI / UDI-DI
00609271920491 FDA UDI
FDA Product Code
FMP FDA UDI
GMDN Term
Pressure-management insole, prefabricated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6450 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

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: Pressure-management insole, prefabricated

DARCO® Peg-Assist™ Off-loading Insole by DARCO International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pressure-management insole, prefabricated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
DARCO International, Inc.

Sources (1)

  • FDA UDI d48fc328-4fa4-429a-aed0-235d977b2468 34 fields · synced Jun 9, 2026