| 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 |