FDA.report

Medetz Surgical Instruments

Primary DI
G223IAT3450
Brand
Medetz Surgical Instruments
Company
Medetz Surgical Instruments LLC
Model
iat-.3-45
Device description
I/A 45 Degree Tip ONLY, 16ga Outer Sleeve, 21ga Closed Inner Cannula tip with .3mm Aspirating Port, 20mm Straight Shaft, Female Connector on Irrigation Line and Male Connecter on Aspirating Line, 45mm Overall Length,
Published
2023-04-10
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
false

Related Records

Contact Domains

Product Codes

CodeName
KYGDevice, Irrigation, Ocular Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
KYGDevice, Irrigation, Ocular SurgeryOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G223IAT3450PrimaryHIBCC0

GMDN Terms

TermDefinition
Ophthalmic surgical irrigation/infusion/aspiration handle, reusableA hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8004205135emichaels@medetzsurgical.com

Regulatory Flags

DUNS number
876570990
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
G2231135500Medetz Surgical Instruments11-35502025-12-16
G2231135900Medetz Surgical Instruments11-35902025-12-16
G2231394680Sinskey lens manipulating hook13-94682025-12-16
G223M1129350Femtosecond Spatulam11-29352025-12-16
G223113858L0Medetz Surgical Instruments11-3858L2025-09-05
G2231140730Medetz Surgical Instruments11-40732025-09-05
G22312449840Medetz Surgical Instruments12-449842025-09-05
G22312479090Medetz Surgical Instruments12-479092025-09-05
G2231310110Medetz Surgical Instruments13-10112025-09-05
G22312406080Medetz Surgical Instruments12-406082025-08-21
G2231109830Medetz Surgical Instruments11-09832025-08-11
G2231115290Medetz Surgical Instruments11-15292025-08-11
G2231196790Medetz Surgical Instruments11-96792025-08-11
G22312244990Medetz Surgical Instruments12-244992025-08-11
G2231244970T0Medetz Surgical Instruments12-44971t2025-08-11
G2231458300Medetz Surgical Instruments14-58302025-08-11
G223997034050Medetz Surgical Instruments99-7034052025-08-11
G2231523360Medetz Surgical Instruments15-23362025-06-30
G2231317450Medetz Surgical Instruments13-17452025-06-26
G223M1113100Medetz Surgical Instrumentsm11-13102025-06-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B090MT2021MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
00757770636266Bausch + LombBausch & Lomb IncorporatedKYG2025-08-05
00757770483402Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
00757770492329Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
00757770406463Bausch + LombBausch & Lomb IncorporatedKYG2024-11-21
00194613022938MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613022945MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023959MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023973MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044817MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044824MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613046101MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060091MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060633MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613088057MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613090340MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
G223IAT3S45Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-06-17
G223IAT3S450Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-05-23
08058340220710Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08058340220727Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
08058340220734Passive Reservoir AKTIVE SRLKYG2024-01-11
08058340220741Active ReservoirAKTIVE SRLKYG2024-01-11
08056477557518Dual Bore Cannula 27GAKTIVE SRLKYG2024-01-11
08056477559598Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2023-12-19
08058340220994Dual Bore Cannula 20GAKTIVE SRLKYG2023-12-19
08058340221007Dual Bore Cannula 23GAKTIVE SRLKYG2023-12-19
08058340221014Dual Bore Cannula 25GAKTIVE SRLKYG2023-12-19
08056477559604Dual Bore Cannula 25G, 36mmAKTIVE SRLKYG2023-12-19