FDA.reportPublic FDA data

Gen2

Primary DI
G277G2E170550
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E17055
Catalog number
G2E17055
Device description
HOUSE SUCTION IRRIGATOR 4x5 FR
Published
2022-09-22
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
JZFTube, Ear Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2E170550PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), whilst providing illumination of the site. It is not dedicated to dental, intrauterine, or liposuction procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It has a built-in light or fibreoptic bundle for illumination. The device may incorporate a handle with side valve(s)/hole(s) for the control of irrigation/aspiration, and may be provided with a stylet, sheath, and/or connection tubing. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8882472477customerservice@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
09348811000736INKAThe Trustee for KAISER FAMILY TRUSTJZF2025-11-21
08904428724017OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724024OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724031OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724048OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428724055OSSEOUS Suction Tube - Fine TipEON MEDITECH PRIVATE LIMITEDJZF2024-07-05
08904428722853OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722877OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722891OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722907OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722914OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722921OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722938OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722945OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722952OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722969OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722976OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722983OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428722990OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723003OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723010OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723027OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723034OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723041OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723058OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723065OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723072OSSEOUS Frazier Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723089OSSEOUS Zoellner Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723096OSSEOUS Zoellner Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04
08904428723102OSSEOUS Zoellner Suction Tube for Ear-DisposableEON MEDITECH PRIVATE LIMITEDJZF2024-07-04