FDA.reportPublic FDA data

Medetz Surgical Instruments

Primary DI
G223863050
Brand
Medetz Surgical Instruments
Company
Medetz Surgical Instruments LLC
Model
8-6305
Device description
Langenbeck Elevator Sharp
Published
2023-08-31
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
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G223863050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
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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

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Primary DI, Brand, Company table
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B382SD9070451100Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD907075030Surgical DirectSurgical Direct, Inc.GEG2026-07-14
B382SD92268003T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268030T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268031T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268032T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268033T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268034T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268035T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
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B382SD92268037T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268038T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268039T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268040T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268041T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
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B382SD92268044T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268045T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268046T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268047T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD92268048T0Surgical DirectSurgical Direct, Inc.GEG2026-07-10
B382SD9147091800Surgical DirectSurgical Direct, Inc.GEG2026-07-09
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