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Rosidal

FDA UDI

Class I (US FDA UDI)

by Lohmann & Rauscher International GmbH & Co KG

Identity

Trade Name
Rosidal FDA UDI
Generic Name
Compression bandaging kit FDA UDI
Device Name
Leg Ulcer Compression System for venous leg ulcer compression therapy. FDA UDI
Model / Reference
Sys FDA UDI
Description
Leg Ulcer Compression System for venous leg ulcer compression therapy. FDA UDI

Identifiers

Catalog Number
16984 FDA UDI
Primary DI / UDI-DI
04021447969206 FDA UDI
FDA Product Code
PYK FDA UDI
GMDN Term
Compression bandaging kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4014 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

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Compression bandaging kit

Rosidal by Lohmann & Rauscher International GmbH & Co KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Compression bandaging kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lohmann & Rauscher International GmbH & Co KG

Sources (1)

  • FDA UDI e7dfa92a-d0db-48f7-bd9f-ee50119e2176 35 fields · synced May 30, 2026