← Back to catalogue

Aequalis Reversed II

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
Aequalis Reversed II FDA UDI
Generic Name
Humeral head spacer prosthesis trial FDA UDI
Device Name
Humeral Spacer Trial FDA UDI
Model / Reference
MWB190 FDA UDI
Description
Humeral Spacer Trial FDA UDI

Identifiers

Catalog Number
MWB190 FDA UDI
Primary DI / UDI-DI
03700386969218 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Humeral head spacer prosthesis trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 36 Millimeter FDA UDI

Category: Humeral head spacer prosthesis trial

Aequalis Reversed II by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Humeral head spacer prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI d24962ea-b060-4bc7-9130-c547a8a9de47 36 fields · synced May 30, 2026