FDA.report

Irrigation Tray with 60cc Piston Syringe

Primary DI
00616784426839
Brand
Irrigation Tray with 60cc Piston Syringe
Company
DYNAREX CORPORATION
Model
4268
Device description
Irrigation Tray with 60cc Piston Syringe: 800cc Outer Basin Tray, 500cc Plastic Graduate, Irrigation Piston Syringe, Protective Cap, Waterproof Drape, Antiseptic Wipe
Published
2021-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KYZSyringe, Irrigating (Non Dental)

Product Code Classifications

CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784426839PackageGS120In Commercial Distribution
00616784426822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784426839006167844268396167844268390616784426839
00616784426822006167844268226167844268220616784426822

GMDN Terms

TermDefinition
Ear canal irrigation kit, single-useA collection of items intended to be used to flush cerumen (ear wax) out of the ear canal during an ear/nose/throat (ENT) procedure. It consists of a manual syringe and other accessory items. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00861092002606CeaLogic Ratio Applicator KitRECIBIO, INC.KYZ2026-03-01
00850027492995NavägeRhinosystems, Inc.KYZ2026-02-23
50192253068854MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068860MonojectCardinal Health 200, LLCKYZ2026-01-29
50192253068885MonojectCardinal Health 200, LLCKYZ2026-01-29
50192253068892MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253007449MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007487MonojectCardinal Health 200, LLCKYZ2025-12-15
50192253007518MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007531MonojectCardinal Health 200, LLCKYZ2025-12-15
20192253007555MonojectCardinal Health 200, LLCKYZ2025-12-15
50192253007730MonojectCardinal Health 200, LLCKYZ2025-12-15
00850063139441Neil Medical Group Neil Medical GroupKYZ2025-12-08
05413765580970RECOTHROM SPRAY KITBAXTER HEALTHCARE CORPORATIONKYZ2025-12-01
50198956194647CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-08
50198956181548CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-08-14
00810180841931Syringes without Needle, Non-Toxic, Luer Slip, 20 ML Dynarex CorporationKYZ2025-05-30
00810180841948Syringes without Needle, Non-Toxic, Luer Slip, 60 MLDynarex CorporationKYZ2025-05-30
10661392002255LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002262LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002842LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002859LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392002927LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392004440LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392004457LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392004464LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008394LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008400LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008417LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
10661392008424LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16