FDA.reportPublic FDA data

Medetz Surgical Instruments

Primary DI
G22313100
Brand
Medetz Surgical Instruments
Company
Medetz Surgical Instruments LLC
Model
1310
Device description
3K 10CM ROUND KNURLED Handle
Published
2022-02-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G22313100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. 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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G2231225050T0Medetz Surgical Instruments12-25050T2026-10-01
G2231337690Medetz Surgical Instruments13-37692026-10-01
G223M111991S0Medetz Surgical Instrumentsm11-1991s2026-10-01
G223M1122750Medetz Surgical Instrumentsm11-22752026-10-01
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
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00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
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00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
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