Couture Essence

FDA UDI

Class I (US FDA UDI)

by Carolon Co.

Identity

Trade Name: Couture Essence FDA UDI
Generic Name: Compression/pressure sock/stocking, reusable FDA UDI
Model / Reference: Thigh FDA UDI

Identifiers

Catalog Number: 0821404 FDA UDI
Primary DI / UDI-DI: 00078301881444 FDA UDI
FDA Product Code: FQL FDA UDI
GMDN Term: Compression/pressure sock/stocking, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5780 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Compression/pressure sock/stocking, reusable

Couture Essence by Carolon Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Carolon Co.

Sources (1)

FDA UDI 1fe5a5e0-8e8d-451c-8cf3-0ec6c4a607ec 33 fields · synced May 31, 2026