FDA.report

Air-Water Syringe Tip

Primary DI
00616784223131
Brand
Air-Water Syringe Tip
Company
DYNAREX CORPORATION
Model
2231
Device description
Air-Water Syringe Tips, Blue
Published
2021-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EHZEvacuator, Oral Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784223131PackageGS140In Commercial Distribution
00616784223124PrimaryGS10
00616784223117Unit of UseGS10
00810180843546Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784223131006167842231316167842231310616784223131
00616784223124006167842231246167842231240616784223124
00616784223117006167842231176167842231170616784223117
00810180843546008101808435468101808435460810180843546

GMDN Terms

TermDefinition
Dental delivery system irrigation handpieceA hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
250
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
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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