Aequalis™ Flex Revive™

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: AEQUALIS™ FLEX REVIVE™ FDA UDI
Generic Name: Shoulder prosthesis screw FDA UDI
Model / Reference: ARS655119 FDA UDI

Identifiers

Catalog Number: ARS655119 FDA UDI
Primary DI / UDI-DI: 00846832072279 FDA UDI
FDA Product Code: HSD FDA UDI
KWS FDA UDI
PHX FDA UDI
GMDN Term: Shoulder prosthesis screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3690 FDA UDI
888.3660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Shoulder prosthesis screw

Aequalis™ Flex Revive™ by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoulder prosthesis screw.

Comprehensive Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
COMPREHENSIVE SRS — Biomet Orthopedics, Inc. · Class II
COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
Humelock II Cementless Shoulder System — FX SOLUTIONS · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II
HemiCAP® — ARTHROSURFACE INCORPORATED · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Tornier, Inc.

Sources (1)

FDA UDI 37e39287-dda4-4e36-9cbb-6aea425784f0 35 fields · synced May 30, 2026