Primary Device ID | 04049539066473 |
NIH Device Record Key | e49886e0-e98c-4416-b587-c1e8c31bd953 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ARTEVO 800 |
Version Model Number | 6647 |
Company DUNS | 342228620 |
Company Name | Carl Zeiss Meditec AG |
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 | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04049539066473 [Primary] |
HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-03-31 |
Device Publish Date | 2023-03-23 |
04049471100143 - Treatment Pack (Size M) | 2024-02-19 single use accessory for ZEISS femtosecond lasers |
04049471100150 - Treatment Pack (Size L) | 2024-02-19 single use accessory for ZEISS femtosecond lasers |
04049471100167 - Treatment Pack (Type KP) | 2024-02-19 single use accessory for ZEISS femtosecond lasers |
04049471100136 - Treatment Pack (Size S) | 2024-02-16 single use accessory for ZEISS femtosecond lasers |
04049539101341 - EyeMag Smart | 2023-11-16 |
04049539101358 - EyeMag Pro S | 2023-11-16 |
04049539101365 - EyeMag Pro F | 2023-11-16 |
04049539064103 - PENTERO® 800 S | 2023-09-19 |