FDA.reportPublic FDA data

High pressure injection/aspiration system with syringe - Connector A

Primary DI
08056477557181
Brand
High pressure injection/aspiration system with syringe - Connector A
Company
AKTIVE SRL
Model
AK-0383/AS
Catalog number
AK-0383/AS
Device description
High pressure injection/aspiration system with syringe - Connector A
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
08052276019714PrimaryGS10
08056477557181Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052276019714080522760197148052276019714
08056477557181080564775571818056477557181

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
08052276027290Dual Bore Cannula 23G, 36mmAK-0519/XLAK-0519/XL2025-06-04
00805227602729Dual Bore Cannula 23G, 36mmAK-0519/XLAK-0519/XL2023-12-19
08052276029638Eye Shield AK-2000AK-20002024-01-15
08052276033635Phaco Slit Knife 2.4 mm Bevel Up Angled F-24/AF-24/A2024-01-17
08052276033642Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionF-24/AP1F-24/AP12024-01-17
08052276033659Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionF-24/AP2F-24/AP22024-01-17
08052276033666Phaco Slit Knife 2.65 mm Bevel Up Angled F-26/AF-26/A2024-01-17
08052276033673Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionF-26/AP1F-26/AP12024-01-17
08052276033680Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionF-26/AP2F-26/AP22024-01-17
08052276033697Phaco Slit Knife 2.75 mm Bevel Up AngledF-27/AF-27/A2024-01-17
08052276033703Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionF-27/AP1F-27/AP12024-01-17
08052276033710Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionF-27/AP2F-27/AP22024-01-17
08052276033727Phaco Slit Knife 2.85 mm Bevel Up Angled F-28/AF-28/A2024-01-17
08052276033734Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionF-28/AP1F-28/AP12024-01-17
08052276033741Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionF-28/AP2F-28/AP22024-01-17
08052276033758Phaco Slit Knife 3.0 mm Bevel Up AngledF-30/AF-30/A2024-01-17
08052276033765Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionF-30/AP1F-30/AP12024-01-17
08052276033772Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionF-30/AP2F-30/AP22024-01-17
08052276033789Phaco Slit Knife 3.2 mm Bevel Up Angled F-32/AF-32/A2024-01-17
08052276033796Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionF-32/AP1F-32/AP12024-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770636105Bausch + LombBausch & Lomb IncorporatedKYG2026-04-30
B090MT2020MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
B090MT2021MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
G22312647930Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2025-11-05
00757770636266Bausch + LombBausch & Lomb IncorporatedKYG2025-08-05
00757770483402Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
00757770492329Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
B090MT20000MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
08052276027290Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2025-06-04
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
08052276026354Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08052276026361Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
08052276026378Passive Reservoir AKTIVE SRLKYG2024-01-11
08052276026385Active ReservoirAKTIVE SRLKYG2024-01-11
08052276027450Dual Bore Cannula 27GAKTIVE SRLKYG2024-01-11