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Varilite

FDA UDI

Class I (US FDA UDI)

by Cascade Designs, Inc.

Identity

Trade Name
Varilite FDA UDI
Generic Name
Air-filled chair cushion FDA UDI
Device Name
Stratus System, 18X18, INC FDA UDI
Model / Reference
Stratus FDA UDI
Description
Stratus System, 18X18, INC FDA UDI

Identifiers

Catalog Number
58840 FDA UDI
Primary DI / UDI-DI
00040818588406 FDA UDI
FDA Product Code
KIC FDA UDI
GMDN Term
Air-filled chair cushion FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3175 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Air-filled chair cushion

Varilite by Cascade Designs, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Air-filled chair cushion.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9f30bbb3-6cf2-467e-93d4-835c1618aed7 35 fields · synced May 31, 2026