Primary Device ID | 23700773723915 |
NIH Device Record Key | f910fda0-9191-4e0c-98a8-250bfa90e5f6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PRECIVIA® Version P |
Version Model Number | S5.200.P |
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 | 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 |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 13700773723918 [Primary] |
GS1 | 23700773723915 [Package] Contains: 13700773723918 Package: [25 Units] In Commercial Distribution |
HNC | Specula, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-02 |
Device Publish Date | 2021-05-25 |
13700773735096 - OPHTACATH® 2 mm Unilateral Kit | 2024-01-05 A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic |
13700773735102 - OPHTACATH® 2 mm Bilateral Kit | 2024-01-05 A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic |
13700773735119 - OPHTACATH® 3 mm Unilateral Kit | 2024-01-05 A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic |
13700773735126 - OPHTACATH® 3 mm Bilateral Kit | 2024-01-05 A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic |
23700773734768 - TearSaver® - 0.4 mm | 2023-11-21 Punctum plug |
23700773734775 - TearSaver® - 0.5 mm | 2023-11-21 Punctum plug |
23700773734782 - TearSaver® - 0.6 mm | 2023-11-21 Punctum plug |
23700773734799 - TearSaver® - 0.7 mm | 2023-11-21 Punctum plugs |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRECIVIA 79268109 not registered Live/Pending |
Sharpsight B.V. 2019-07-08 |