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Sizers Set (enucleation / Evisceration) Single Use

FDA UDI

Class II (US FDA UDI)

by Fci S A S Fci 20 22

Identity

Trade Name
SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE FDA UDI
Generic Name
Surgical implant template, single-use FDA UDI
Device Name
A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device. FDA UDI
Model / Reference
S6.3060 FDA UDI
Description
A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device. FDA UDI

Identifiers

Primary DI / UDI-DI
03760087123715 FDA UDI
FDA Product Code
HPZ FDA UDI
GMDN Term
Surgical implant template, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.3320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical implant template, single-use

Sizers Set (enucleation / Evisceration) Single Use by Fci S A S Fci 20 22 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical implant template, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fci S A S Fci 20 22

Sources (1)

  • FDA UDI 93bc0876-15da-4c2a-bd25-044ebd872684 33 fields · synced May 30, 2026