FDA.reportPublic FDA data

Medetz Surgical Instruments

Primary DI
G2231310110
Brand
Medetz Surgical Instruments
Company
Medetz Surgical Instruments LLC
Model
13-1011
Device description
"Vienna Nasal Speculum Size 2 BL 30.0mm OL 135mm(5 3/8"")"
Published
2025-09-05
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
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G2231310110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. 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

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Primary DI, Brand, Company table
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00810238290100PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290117PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290124PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
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