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Oasis Elite

FDA UDI

Class I (US FDA UDI)

by Trulife, Inc.

Identity

Trade Name
Oasis Elite FDA UDI
Generic Name
Operating table patient pressure distribution pad, reusable FDA UDI
Device Name
Oasis Elite Open Head Ring, Adult FDA UDI
Model / Reference
EL022G FDA UDI
Description
Oasis Elite Open Head Ring, Adult FDA UDI

Identifiers

Primary DI / UDI-DI
00643293028940 FDA UDI
FDA Product Code
JZR FDA UDI
GMDN Term
Operating table patient pressure distribution pad, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.4900 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating table patient pressure distribution pad, reusable

Oasis Elite by Trulife, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating table patient pressure distribution pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trulife, Inc.

Sources (1)

  • FDA UDI 81213930-5f36-4bbf-bd9f-99db66c77193 33 fields · synced Jun 4, 2026