| Primary Device ID | 03760087126297 | 
| NIH Device Record Key | ad12ea6b-edfe-4f97-bb3d-5e1afdbf6d44 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Orbital sphere implant introducer | 
| Version Model Number | SPHERE INTRODUCER | 
| Catalog Number | S6.3050u | 
| Company DUNS | 763408366 | 
| Company Name | FCI S A S FCI 20 22 | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| 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 | 
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | |
| Phone | 800-932-4202 | 
| orders@fci-ophthalmics.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 03760087126297 [Primary] | 
| HNR | Forceps, Ophthalmic | 
| Steralize Prior To Use | true | 
| Device Is Sterile | true | 
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
[03760087126297]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-03-04 | 
| Device Publish Date | 2020-02-25 | 
| 03760087126297 | A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant i | 
| 03760087126389 | A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant i |