← Back to catalogue

Aequalis™ Flex Revive™

FDA UDI

Class II (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name
AEQUALIS™ FLEX REVIVE™ FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Model / Reference
ARS742205 FDA UDI

Identifiers

Catalog Number
ARS742205 FDA UDI
Primary DI / UDI-DI
00846832068654 FDA UDI
FDA Product Code
KWS FDA UDI
PHX FDA UDI
HSD FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3690 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 17 Millimeter FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

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

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

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 89968541-c3ff-4d03-b05d-55a632f8b4c3 35 fields · synced May 31, 2026