FDA.reportPublic FDA data

The Morgan Lens Ocular Irrigation Convenience Kit

Primary DI
B090MT20631
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
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
017535668
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B090MT2021MorTanMT202 2026-02-10
B090XC2201451XO ConstrainXC2.20-1452026-02-03
10850068519238SAM Medical IO8422025-12-09
10850068519245SAM Medical IO847W-1P2025-12-09
10850068519252SAM Medical IO846W-1P2025-12-09
10850068519269SAM Medical IO845W-1P2025-12-09
B090P110901VentiV ScientificP11-090P11-0902025-11-24
B090P11090F1VentiV ScientificP11-090-FP11-090-F2025-11-24
10850049994863Syntervention 4008-2032025-09-26
10850049994870Syntervention 4008-3032025-09-26
10850049994887Syntervention 4008-4032025-09-26
10850049994894Syntervention 4008-2052025-09-26
10850049994900Syntervention 4008-3052025-09-26
10850049994917Syntervention 4008-4052025-09-26
10850049994924Syntervention 4008-2072025-09-26
10850049994931Syntervention 4008-3072025-09-26
10850049994948Syntervention 4008-4072025-09-26
10850049994955Syntervention 4008-2092025-09-26
10850049994962Syntervention 4008-3092025-09-26
10850049994979Syntervention4007-4092025-09-26

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