FDA.reportPublic FDA data

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

Product Codes#

Code, Name table
CodeName
KYZSyringe, Irrigating (Non Dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784426839PackageGS120In Commercial Distribution
00616784426822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784426839006167844268396167844268390616784426839
00616784426822006167844268226167844268220616784426822

GMDN Terms#

Term, Definition table
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 table
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

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00840117322554Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363712026-10-23
00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363722026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363732026-10-23
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00840117339057Durma+ Transparent Film Dressing, Frame Style, Sterile36472024-12-13
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