FDA.reportPublic FDA data

Super Bypass

Primary DI
04580036675114
Brand
Super Bypass
Company
TAKAYAMA INSTRUMENTS INC.
Model
SSTi-MY22L
Catalog number
SSTi-MY22L
Device description
Suction-Irrigation MiNi Hand-Piece, Left-Handed
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580036675114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580036675114045800366751144580036675114

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration cannula, non-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), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
707948014
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580036672748KamiyamaK-101-1K-101-12025-06-26
04580036672755KamiyamaK-101-2K-101-22025-06-26
04580036672762KamiyamaK-102-1K-102-12025-06-26
04580036672779KamiyamaK-102-2K-102-22025-06-26
04580036672786KamiyamaK-103K-1032025-06-26
04580036672793KamiyamaK-104K-1042025-06-26
04580036672809KamiyamaK-110-1K-110-12025-06-26
04580036672816KamiyamaK-110-2K-110-22025-06-26
04580036672823KamiyamaK-111-1K-111-12025-06-26
04580036672830KamiyamaK-111-2K-111-22025-06-26
04580036672847KamiyamaK-3030K-30302025-06-26
04580036672854KamiyamaK-3010K-30102025-06-26
04580036672861KamiyamaK-203K-2032025-06-26
04580036672878KamiyamaK-1030K-10302025-06-26
04580036672885KamiyamaK-2030K-20302025-06-26
04580036672892KamiyamaK-2010K-20102025-06-26
04580036672908KamiyamaKTP-120KTP-1202025-06-26
04580036672915KamiyamaKTP-230KTP-2302025-06-26
04580036672922KamiyamaKTP-340KTP-3402025-06-26
04580036672939KamiyamaKTP-1520KTP-15202025-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G453332414200PEAK MEDICALPeak Medical Distribution Inc.GEA2026-05-08
G589DS22G501DermaSculptCosmoFranceGEA2026-04-13
G589DS22G701DermaSculptCosmoFranceGEA2026-04-13
G589DS23G301DermaSculptCosmoFranceGEA2026-04-13
G589DS23G401DermaSculptCosmoFranceGEA2026-04-13
G589DS23G501DermaSculptCosmoFranceGEA2026-04-13
G589DS25G401DermaSculptCosmoFranceGEA2026-04-13
G589DS25G501DermaSculptCosmoFranceGEA2026-04-13
G589DS27G251DermaSculptCosmoFranceGEA2026-04-13
G589DS27G401DermaSculptCosmoFranceGEA2026-04-13
G589DS27G501DermaSculptCosmoFranceGEA2026-04-13
G589DS30G251DermaSculptCosmoFranceGEA2026-04-13
10192253037906MonojectCardinal Health 200, LLCGEA2026-04-07
10192253037913MonojectCardinal Health 200, LLCGEA2025-10-10
10669808004008SoftFil® EasyGuideProllenium MedicalGEA2025-08-28
10669808004084SoftFil® PrecisionProllenium MedicalGEA2025-08-28
10192253003444ArgyleCardinal Health 200, LLCGEA2024-10-09
10192253003451ArgyleCardinal Health 200, LLCGEA2024-10-09
10850013527028DannikDannik LLCGEA2023-01-21
10850013527073DannikDannik LLCGEA2023-01-21
10850013527080DannikDannik LLCGEA2023-01-21
10850013527097DannikDannik LLCGEA2023-01-21
10850013527103DannikDannik LLCGEA2023-01-21
10850013527110DannikDannik LLCGEA2023-01-21
10850013527127DannikDannik LLCGEA2023-01-21
10850013527134DannikDannik LLCGEA2023-01-21
10850013527141DannikDannik LLCGEA2023-01-21
10850013527158DannikDannik LLCGEA2023-01-21
10850013527165DannikDannik LLCGEA2023-01-21
10850013527172DannikDannik LLCGEA2023-01-21