The Morgan Lens Ocular Irrigation Convenience Kit

GUDID B090MT20631

ZIEN MEDICAL TECHNOLOGIES, INC.

General surgical procedure kit, non-medicated, single-use
Primary Device IDB090MT20631
NIH Device Record Key6af90457-1b2d-499b-9a32-9bb372e8ffb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Morgan Lens Ocular Irrigation Convenience Kit
Version Model NumberMT2063
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB090MT20630 [Primary]
HIBCCB090MT20631 [Package]
Contains: B090MT20630
Package: Shelf Carton [12 Units]
In Commercial Distribution

FDA Product Code

PZGSurgical Eye Tray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-11
Device Publish Date2025-03-03

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

B090MT20631 - The Morgan Lens Ocular Irrigation Convenience Kit 2025-03-11
B090MT20631 - The Morgan Lens Ocular Irrigation Convenience Kit 2025-03-11
00860412001572 - SAM Medical2024-11-18 Repositionable Chest Tube (RCT) catheters intended for use in pleural fluid drainage.
00850068519057 - SAM Medical2024-11-08 The SAM IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proxima
00850068519088 - SAM Medical2024-11-08 The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (prox
00850068519118 - SAM Medical2024-11-08 The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, distal tibia and humeral head (prox
B0902P0130B1 - Knight Microcatheter2024-05-08 The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective inf
B0902P0130S1 - Knight Microcatheter2024-05-08 The Knight microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective inf
B090E20130B1 - XO Cath2024-05-08 The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used for controlled and selective in

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.