FDA.reportPublic FDA data

Gen2

Primary DI
G277G2E9009630
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E900963
Catalog number
G2E900963
Device description
HOUSE FOOTPLATE CHISEL STR
Published
2022-09-23
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
JYEChisel, Middle-Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYEChisel, Middle-EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2E9009630PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear chiselA single-blade bevelled surgical instrument intended for use in cutting or contouring the bones of the middle ear, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp and can be either straight or angled. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags#

DUNS number
080402644
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
00840343727437Gen2G2N99753G2N997532026-04-23
00840343727567Gen2G2G37293G2G372932026-04-23
00840343727574Gen2G2N99755G2N997552026-04-23
00840343727581Gen2G2C62489G2C624892026-04-23
00840343727451Gen2G2N49254G2N492542026-04-22
00840343727468Gen2G2G37278G2G372782026-04-22
00840343727475Gen2G2G37279G2G372792026-04-22
00840343727482Gen2G2G35954G2G359542026-04-22
00840343727499Gen2G2C62277G2C622772026-04-22
00840343727505Gen2G2C62434G2C624342026-04-22
00840343727512Gen2G2N48672TCG2N48672TC2026-04-22
00840343727529Gen2G2N87457G2N874572026-04-22
00840343727536Gen2G2N99517G2N995172026-04-22
00840343727543Gen2G2G37282G2G372822026-04-22
00840343727550Gen2G2O917144G2O9171442026-04-22
00840343727291GEN2G2E901343G2E9013432026-04-16
00840343727307GEN2G2E901344G2E9013442026-04-16
00840343727314GEN2G2E901345G2E9013452026-04-16
00840343727321GEN2G2E900935G2E9009352026-04-16
00840343727338GEN2G2N52380G2N523802026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770405220Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770409693Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770413140Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770417766Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770418695Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770424078Bausch + LombBausch & Lomb IncorporatedJYE2025-08-08
00757770676439Bausch + LombBausch & Lomb IncorporatedJYE2025-08-05
00888515134157BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515228177BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229013BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229020BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515229099BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230033BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230040BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230057BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
00888515230064BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.JYE2024-02-28
G586E7214220Novo SurgicalNOVO SURGICAL, INC.JYE2023-12-18
G586E7214730Novo SurgicalNOVO SURGICAL, INC.JYE2023-12-18
00190776319052MillenniumAvalign Technologies, Inc.JYE2023-06-23
00840343716868GEN2SURGIX MEDICAL LLCJYE2023-06-02
00840343716875GEN2SURGIX MEDICAL LLCJYE2023-06-02
00840343716882GEN2SURGIX MEDICAL LLCJYE2023-06-02
14026704805157PILLINGTELEFLEX INCORPORATEDJYE2022-12-08
54026704805155PILLINGTELEFLEX INCORPORATEDJYE2022-12-08
00840343700607Gen2SURGIX MEDICAL LLCJYE2022-10-18
00887482039755Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYE2022-09-28
00190660008796Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-07
00190660008802Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-07
00190660008550Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-04
00190660008819Ambler SurgicalAMBLER SURGICAL CORP.JYE2021-01-04