FDA.reportPublic FDA data

Medetz Surgical Instruments

Primary DI
G223110687A0
Brand
Medetz Surgical Instruments
Company
Medetz Surgical Instruments LLC
Model
11-1687a
Device description
Kelly decemet membrane punch
Published
2023-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNJPunch, Corneo-Scleral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNJPunch, Corneo-ScleralOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G223110687A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Corneoscleral punchA hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue (frequently in the form of a disc) from the sclera or cornea of a patient or from grafts taken from cadaver donors. It typically has a set of sharp, hollow tips at the distal end (a rotary mechanism that may be either integral or an attachment) operated by squeezing a two-part handle. The device is used mainly to perform ophthalmic graft implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8004205135emichaels@medetzsurgical.com

Regulatory Flags#

DUNS number
876570990
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G22312349490Medetz Surgical Instruments12-349492026-08-03
G22312552000Medetz Surgical Instruments12-552002026-08-03
G22314029320Medetz Surgical Instruments14-0293-22026-08-03
G223140475250Medetz Surgical Instruments14-0475-252026-08-03
G223A1140970Medetz Surgical InstrumentsA11-40972026-08-03
G2231114060Medetz Surgical Instruments11-14062026-07-27
G2231119000Medetz Surgical Instruments11-19002026-07-27
G223111901T0Medetz Surgical Instruments11-1901T2026-07-27
G22312042490Medetz Surgical Instruments12-042492026-07-27
G22312240810Medetz Surgical Instruments12-240812026-07-27
G22312408910Medetz Surgical Instruments12-408912026-07-27
G223140190270Medetz Surgical Instruments14-0190272026-07-27
G223140340L0Medetz Surgical Instruments14-0340LT2026-07-27
G223140410T0Medetz Surgical Instruments14-0410-T2026-07-27
G223145830T0Medetz Surgical Instruments14-5830-t2026-07-27
G22315466860Medetz Surgical Instruments15-466862026-07-27
G2231250500Fine Thornton Fixation Ring12-250502022-02-24
G22312643590Medetz Surgical Instruments12-643592026-04-09
G2231349550Ophthalmic Scissors13-49552026-04-09
G223140461200Medetz Surgical Instruments14-0461202026-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770419807Bausch + LombBausch & Lomb IncorporatedHNJ2026-04-29
00757770500437Bausch + LombBausch & Lomb IncorporatedHNJ2025-08-15
00194613036690MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086510MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086527MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086879MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087005MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087012MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087463MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087555MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613099756MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613100049MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613103453MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108281MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108809MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108816MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109646MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109691MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109707MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110260MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110307MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110390MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110406MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110857MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110994MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111397MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111908MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613123604MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01