FDA.reportPublic FDA data

Aztec

Primary DI
B87110291120
Brand
Aztec
Company
Aztecmed/Ent LLC
Model
10-29112
Catalog number
10-29112
Device description
Baron Suction Tube, 7 french
Published
2020-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
B87110291120PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
117559084
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B87110221000Aztec10-2210010-221002020-10-06
B87110221010Aztec10-2210110-221012020-10-06
B87110221020Aztec10-2210210-221022020-10-06
B87110221030Aztec10-2210310-221032020-10-06
B87110221040Aztec10-2210410-221042020-10-06
B87110221050Aztec10-2210510-221052020-10-06
B87110243570Aztec10-2435710-243572020-10-07
B87110243620Aztec10-2436210-243622020-10-07
B87110244000Aztec10-2440010-244002020-10-07
B87110244140Aztec10-2441410-244142020-10-07
B87110250000Aztec10-2500010-250002020-10-07
B87110251100Aztec10-2511010-251102020-10-07
B87110251110Aztec10-2511110-251112020-10-07
B87110243500Aztec10-2435010-243502020-10-06
B87110243520Aztec10-2435210-243522020-10-06
B87110243560Aztec10-2435610-243562020-10-06
B87111242000Aztec11-2420011-242002020-10-09
B87111242010Aztec11-2420111-242012020-10-09
B87111242020Aztec11-2420211-242022020-10-09
B87111245000Aztec11-2450011-245002020-10-09

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