FDA.reportPublic FDA data

The Morgan Lens Ocular Irrigation Convenience Kit

Primary DI
B090MT20630
Brand
The Morgan Lens Ocular Irrigation Convenience Kit
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
MT2063
Published
2025-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PZGSurgical Eye Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZGSurgical Eye TrayOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090MT20631PackageHIBCC12In Commercial Distribution
B090MT20630PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
017535668
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

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00850068519279SAM MedicalIO805IO8052026-05-07
00850068519309SAM MedicalIO806IO8062026-05-07
00850068519330SAM MedicalIO807IO8072026-05-07
B090MT630MorTan MT632026-02-17
B090MT2020MorTanMT202 2026-02-10
B090MT2021MorTanMT202 2026-02-10
B090XC2201450XO ConstrainXC2.20-1452026-02-03
B090XC2201451XO ConstrainXC2.20-1452026-02-03
00850068519231SAM Medical IO8422025-12-09
00850068519248SAM Medical IO847W-1P2025-12-09
00850068519255SAM Medical IO846W-1P2025-12-09
00850068519262SAM Medical IO845W-1P2025-12-09
10850068519238SAM Medical IO8422025-12-09
10850068519245SAM Medical IO847W-1P2025-12-09
10850068519252SAM Medical IO846W-1P2025-12-09
10850068519269SAM Medical IO845W-1P2025-12-09
B090P110900VentiV ScientificP11-090P11-0902025-11-24
B090P11090F0VentiV ScientificP11-090-FP11-090-F2025-11-24
B090P110901VentiV ScientificP11-090P11-0902025-11-24
B090P11090F1VentiV ScientificP11-090-FP11-090-F2025-11-24

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16931918105574InvenioGRI Medical & Electronic Technology Co., Ltd.PZG2026-04-10
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