FDA.reportPublic FDA data

Collection bag for Associate REF: 6279.ASD1 Cartridge.

Primary DI
18717872013456
Brand
Collection bag for Associate REF: 6279.ASD1 Cartridge.
Company
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Model
6279.ASD4
Catalog number
6279.ASD4
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
08717872013459PrimaryGS10
18717872013456Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717872013459087178720134598717872013459
1871787201345618717872013456

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgery fluid collection bagA non-sterile synthetic polymer bag intended to be used to collect aspirated materials (e.g., irrigation solution, vitreous humour, blood) from the eye during an ophthalmic surgical procedure, typically phacoemulsification/vitrectomy. It is connected to the surgical system drain port via tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
407522184
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
08717872031804EVA Custom TDC Vitrectomy Pack VGPC Input 23G8523.4222021-06-11
08717872003221Universal silicone infusion line for 20 gauge/0.9 mm cannula system.1279.IA201279.IA202021-02-01
08717872003245Infusion line for 23G / 0.6 mm infusion cannula 1272.ERPP21279.P1279.P2021-02-01
08717872003993Disposable Backflush instrument, with extended silicone tip and active aspiratio1281.TDM1281.TDM2021-02-02
08717872004013Replacement backflush reservoir with active aspiration.1281.XD1281.XD2021-02-02
08717872004075MVR Blade 23-G, angled1282.D061282.D062021-02-09
08717872004099One step stiletto insertor.(23 gauge / 0.6 mm)1282.F061282.F062021-02-09
08717872007403Disposable keratoscope1420.D1420.D2023-09-14
08717872012339Crescent Knife, 2.25, 55°, bevel up51.111851.11182021-01-29
08717872012346Slit Knife, 2.2mm, angled 45°, bibevel51.372251.37222021-01-29
08717872012384MVR Blade 20G, straight51.523051.52302021-01-29
08717872015255Universal silicone infusion line for 20 gauge/0.9 mm cannula system, suitable fo1279.IA20S1279.IA20S2021-02-01
08717872015712MVR Blade 20G, angled52.522052.52202021-01-29
08717872015736Trapezoid Knife 1.2 x 1.4mm, angled53.121453.12142021-01-29
08717872015743Slit Knife, 2.2mm, angled, bevel up53.372253.37222021-01-29
08717872015750Slit Knife, 2.75mm, angled, bevel up53.372753.37272021-01-29
08717872015798Clear Corneal Knife, 2.5mm, angled54.572554.57252021-01-29
08717872015934Stab Knife, 15°51.489151.48912021-01-29
08717872031811EVA Custom TDC Vitrectomy Pack VGPC Input 25G8525.4098525.4012021-06-11
08717872031828EVA Custom TDC Vitrectomy Pack VGPC Input 27G8527.4068525.4012021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047926204Irrigation HandpieceA1 Medical GmbHKYG2026-05-29
04251047930003Aspiration HandpieceA1 Medical GmbHKYG2026-05-29
00757770636105Bausch + LombBausch & Lomb IncorporatedKYG2026-04-30
B090MT2020MorTanZien Medical Technologies, LLCKYG2026-02-10
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
B090MT20000MorTanZien Medical Technologies, LLCKYG2025-06-25
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTanZien Medical Technologies, LLCKYG2025-06-25
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