FDA.reportPublic FDA data

Medetz Surgical Instruments

Primary DI
G2231261409
Brand
Medetz Surgical Instruments
Company
Medetz Surgical Instruments LLC
Model
12-61409
Device description
"Bowman Lacrimal Probe size 0000/000 OL 143mm (5 5/8"")"
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNLProbe, Lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNLProbe, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G2231261409PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. 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
G22312643590Medetz Surgical Instruments12-643592026-04-09
G2231349550Ophthalmic Scissors13-49552026-04-09
G223140461200Medetz Surgical Instruments14-0461202026-04-09
G22351091I0Medetz Surgical Instruments5-1091-I2026-04-09
G2231135500Medetz Surgical Instruments11-35502025-12-16
G2231135900Medetz Surgical Instruments11-35902025-12-16
G2233K0Medetz Surgical Instruments3k2023-07-17
G2231124410Medetz Surgical Instruments11-24412023-04-11
G22313100Medetz Surgical Instruments13102022-02-23
G2231394680Sinskey lens manipulating hook13-94682025-12-16
G223M1129350Femtosecond Spatulam11-29352025-12-16
G223111991RC0Medetz Surgical Instruments11-1991rc2025-11-05
G2231139450Medetz Surgical Instruments11-39452025-11-05
G22312270490Medetz Surgical Instruments12-270492025-11-05
G22312647930Medetz Surgical Instruments12-647932025-11-05
G223140200700Medetz Surgical Instruments14-0200-7.02025-11-05
G223M1120880Colibri Forcepm11-20882025-11-05
G22312624110Medetz Surgical Instruments12-624112025-09-10
G223113858L0Medetz Surgical Instruments11-3858L2025-09-05
G2231140730Medetz Surgical Instruments11-40732025-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090677ELMED INCORPORATEDELMED INCORPORATEDHNL2026-05-12
20757770455953Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
00757770460670Bausch + LombBausch & Lomb IncorporatedHNL2026-04-29
00190776410476MillenniumAvalign Technologies, Inc.HNL2025-09-11
00757770408818Bausch + LombBausch & Lomb IncorporatedHNL2025-08-14
00194613010690MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613010706MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
00194613111731MSI Precision Specialty InstrumentsMed Saver, Inc.HNL2025-08-01
04058935011819Bowman lachrymal probe, 0000-000Bausch & Lomb GmbHHNL2025-07-11
00840343726478GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726485GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726492GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726508GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726515GEN2SURGIX MEDICAL LLCHNL2025-06-16
00840343726522GEN2SURGIX MEDICAL LLCHNL2025-06-16
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G412PH19600MR PHACOCrestpoint Management LimitedHNL2025-06-07
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G412PH197510MR PHACOCrestpoint Management LimitedHNL2025-06-07
G412PH197520MR PHACOCrestpoint Management LimitedHNL2025-06-07
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