FDA.reportPublic FDA data

High pressure injection/aspiration system for syringe - Connector H

Primary DI
08052276015938
Brand
High pressure injection/aspiration system for syringe - Connector H
Company
AKTIVE SRL
Model
AK-0383/H
Catalog number
AK-0383/H
Device description
High pressure injection/aspiration system for syringe - Connector H
Published
2023-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYGDevice, Irrigation, Ocular Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYGDevice, Irrigation, Ocular SurgeryOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052276019905PrimaryGS10
08052276015938Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052276019905080522760199058052276019905
08052276015938080522760159388052276015938

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
433533053
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056477557655Phaco Slit Knife 2.4 mm Bevel Up Angled F-24/AF-24/A2024-01-17
08058340226217Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionF-24/AP1F-24/AP12024-01-17
08052276001665Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionF-24/AP2F-24/AP22024-01-17
08056477557662Phaco Slit Knife 2.65 mm Bevel Up Angled F-26/AF-26/A2024-01-17
08058340226224Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionF-26/AP1F-26/AP12024-01-17
08052276015167Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionF-26/AP2F-26/AP22024-01-17
08056477557679Phaco Slit Knife 2.75 mm Bevel Up AngledF-27/AF-27/A2024-01-17
08058340226248Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionF-27/AP1F-27/AP12024-01-17
08052276015174Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionF-27/AP2F-27/AP22024-01-17
08056477557686Phaco Slit Knife 2.85 mm Bevel Up Angled F-28/AF-28/A2024-01-17
08058340226279Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionF-28/AP1F-28/AP12024-01-17
08052276015181Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionF-28/AP2F-28/AP22024-01-17
08056477557693Phaco Slit Knife 3.0 mm Bevel Up AngledF-30/AF-30/A2024-01-17
08058340226286Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionF-30/AP1F-30/AP12024-01-17
08052276015198Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionF-30/AP2F-30/AP22024-01-17
08056477557709Phaco Slit Knife 3.2 mm Bevel Up Angled F-32/AF-32/A2024-01-17
08058340226293Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionF-32/AP1F-32/AP12024-01-17
08052276015204Phaco Slit Knife 3.2 mm Dual Bevel Angled with protectionF-32/AP2F-32/AP22024-01-17
08052276001689Phaco Slit Knife 3.4 mm Bevel Up Angled with protectionF-34/AP1F-34/AP12024-01-17
08056477557716Scleral Knife Angled G-57/AG-57/A2024-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B090MT2021MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
00757770636266Bausch + LombBausch & Lomb IncorporatedKYG2025-08-05
00757770483402Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
00757770492329Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
00757770406463Bausch + LombBausch & Lomb IncorporatedKYG2024-11-21
00194613022938MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613022945MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023959MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023973MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044817MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044824MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613046101MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060091MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060633MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613088057MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613090340MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
G223IAT3S45Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-06-17
G223IAT3S450Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-05-23
08058340220710Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08058340220727Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
08058340220734Passive Reservoir AKTIVE SRLKYG2024-01-11
08058340220741Active ReservoirAKTIVE SRLKYG2024-01-11
08056477557518Dual Bore Cannula 27GAKTIVE SRLKYG2024-01-11
08056477559598Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2023-12-19
08058340220994Dual Bore Cannula 20GAKTIVE SRLKYG2023-12-19
08058340221007Dual Bore Cannula 23GAKTIVE SRLKYG2023-12-19
08058340221014Dual Bore Cannula 25GAKTIVE SRLKYG2023-12-19
08056477559604Dual Bore Cannula 25G, 36mmAKTIVE SRLKYG2023-12-19