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Aequalis Reversed Ii

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
AEQUALIS REVERSED II FDA UDI
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Model / Reference
DWD195 FDA UDI

Identifiers

Catalog Number
DWD195 FDA UDI
Primary DI / UDI-DI
03700386935930 FDA UDI
FDA Product Code
KWS FDA UDI
PHX FDA UDI
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 42 Millimeter FDA UDI

Category: Shoulder glenoid fossa prosthesis, prefabricated

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

Similar devices

Also classified as Shoulder glenoid fossa prosthesis, prefabricated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tornier, Inc.

Sources (1)

  • FDA UDI 8dcfd182-4ab9-4aca-9caa-be18bba78295 35 fields · synced May 30, 2026