Primary Device ID | 00850007135676 |
NIH Device Record Key | c52db0dd-a72e-4168-8524-e8e4724be64e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear |
Version Model Number | Emerald MAX |
Company DUNS | 969263979 |
Company Name | Euclid Vision Corporation |
Device Count | 1 |
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 | 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 | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com | |
Phone | 1-(800) 477-9396 |
UDI@euclidsys.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850007135676 [Primary] |
NUU | Lens, Contact, Orthokeratology, Overnight |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-08-13 |
Device Publish Date | 2025-08-05 |
00850007135690 | Emerald Elite, tisilfocon A, Green |
00850007135683 | Emerald MAX Toric, tisilfocon A, Green |
00850007135676 | Emerald MAX, tisilfocon A, Green |
00850007135669 | Emerald Elite, tisilfocon A, Blue |
00850007135652 | Emerald MAX Toric, tisilfocon A, Blue |
00850007135645 | Emerald MAX, tisilfocon A, Blue |