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Solidea

FDA UDI

Class II (US FDA UDI)

by Calzificio Pinelli Srl

Identity

Trade Name
SOLIDEA FDA UDI
Generic Name
Compression/pressure tubular garment FDA UDI
Device Name
ELASTIC-COMPRESSION AMBIDEXTROUS GAUNTLET FOR THE MANAGEMENT OF LYMPHEDEMA AND EDEMA OF HAND AND FOREARM. SIZE S, CAMEL, GRADUATED COMPRESSION 25/32 mmHg. FDA UDI
Model / Reference
48879 FDA UDI
Description
ELASTIC-COMPRESSION AMBIDEXTROUS GAUNTLET FOR THE MANAGEMENT OF LYMPHEDEMA AND EDEMA OF HAND AND FOREARM. SIZE S, CAMEL, GRADUATED COMPRESSION 25/32 mmHg. FDA UDI

Identifiers

Catalog Number
0429A5 FDA UDI
Primary DI / UDI-DI
08300496048879 FDA UDI
FDA Product Code
DWL FDA UDI
GMDN Term
Compression/pressure tubular garment FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5780 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

Yes

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

Category: Compression/pressure tubular garment

Solidea by Calzificio Pinelli Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Compression/pressure tubular garment.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Calzificio Pinelli Srl

Sources (1)

  • FDA UDI 01b3cb97-d6e7-4b81-9371-698991d99f36 34 fields · synced Jun 6, 2026