FDA.reportPublic FDA data

Medetz Surgical Instruments

Primary DI
G2231394390
Brand
Medetz Surgical Instruments
Company
Medetz Surgical Instruments LLC
Model
13-9439
Device description
Royce Ear Knife, 8mm, upcutting bld
Published
2023-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JYOKnife, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYOKnife, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G2231394390PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ear knifeA hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
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00757770676316Bausch + LombBausch & Lomb IncorporatedJYO2025-11-14
00844505014694SKULL BASEGrace Medical, Inc.JYO2025-09-26