SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE

GUDID 13760087123712

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: 13760087123712
• NIH Device Record Key: 93bc0876-15da-4c2a-bd25-044ebd872684
• Commercial Distribution Discontinuation: 2026-02-17
• Commercial Distribution Status: Not 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: false
• 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	03760087123715 [Primary]
GS1	13760087123712 [Package]; Contains: 03760087123715; Package: [1 Units]; Discontinued: 2026-02-17; Not in Commercial Distribution

FDA Product Code

• HPZ: Implant, Eye Sphere

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-19
• Device Publish Date: 2021-05-30

Devices Manufactured by FCI S A S FCI 20 22

• 13760087123712 - SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE: 2026-02-19A 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.
• 13760087123712 - SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USE: 2026-02-19 A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during impla
• 23700773707472 - MACULORHEXIS FORCEPS 27 G: 2025-04-04 MACULORHEXIS FORCEPS 27 G
• 23700773707489 - END GRASPING FORCEPS 27 G: 2025-04-04 END GRASPING FORCEPS 27 G
• 23700773707496 - TANO FORCEPS 27 G: 2025-04-04 TANO FORCEPS 27 G
• 23700773707502 - pince super grip 23G: 2025-04-04 pince super grip 23G
• 23700773707519 - pince super grip 25G: 2025-04-04 pince super grip 25G
• 23700773707526 - pince super grip 27G: 2025-04-04 pince super grip 27G
• 23700773721041 - TANO POLISHER,20G: 2025-04-04 TANO POLISHER,20G