Luneau
GUDID 03664188000114
The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.
LUNEAU TECHNOLOGY OPERATIONS
Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover Ophthalmic tonometer tip cover| Primary Device ID | 03664188000114 |
| NIH Device Record Key | ed4a9b04-4d56-444f-a6a2-c9f1d6019d6e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Luneau |
| Version Model Number | Tonometer separation prisms L900 -box of 20 |
| Company DUNS | 260432380 |
| Company Name | LUNEAU TECHNOLOGY OPERATIONS |
| Device Count | 100 |
| 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 | false |
| 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 | 03664188000114 [Unit of Use] |
| GS1 | 03664188000138 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023838
FDA Product Code
| HKY | Tonometer, Manual |
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 | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
On-Brand Devices [Luneau]
| 03664188000107 | The separation prisms is an accessory to the tonometer which is device intended to estimate intr |
| 03664188000114 | The separation prisms is an accessory to the tonometer which is device intended to estimate intr |
Trademark Results [Luneau]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUNEAU 74696483 2036550 Dead/Cancelled |
LUNEAU, S.A. 1995-06-21 |
 LUNEAU 74380876 1900512 Dead/Cancelled |
LUNEAU S.A. 1993-04-16 |
 LUNEAU 73236874 1186076 Dead/Cancelled |
Luneau U.S.A., Inc. 1979-10-29 |
 LUNEAU 73236353 1175624 Dead/Cancelled |
Luneau U.S.A., Inc. 1979-10-23 |
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