SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE

GUDID 13700773728111

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.

FCI S A S FCI 20 22

Surgical implant template, single-use

• Primary Device ID: 13700773728111
• NIH Device Record Key: b9ac88a6-f2a4-4caf-b5b5-909f3a443a82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE
• Version Model Number: S6.3060
• Company DUNS: 763408366
• Company Name: FCI S A S FCI 20 22
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	13700773728111 [Primary]

FDA Product Code

• HPZ: Implant, Eye Sphere

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-25
• Device Publish Date: 2026-02-17

On-Brand Devices [SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE]

• 13760087123712: A device designed to determine the appropriate size and placement of a non-dental implant for a
• 13700773728111: A device designed to determine the appropriate size and placement of a non-dental implant for a