FDA.report

Vortex Irrigation Needle

Primary DI
07640159160052
Brand
Vortex Irrigation Needle
Company
Produits dentaires S.A.
Model
21413
Catalog number
VXIN30G40
Device description
Vortex Irrigation Needle is a flexible cannula with radial opening for liquid ejection along the canal walls. Box of 40 cannulas.
Published
2019-09-10
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

Related Records

Contact Domains

Product Codes

CodeName
EICSyringe, Periodontic, Endodontic, Irrigating
EKICarrier, Amalgam, Operative

Product Code Classifications

CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1
EKICarrier, Amalgam, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640159160052PrimaryGS10
07640159160182Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640159160052076401591600527640159160052
07640159160182076401591601827640159160182

GMDN Terms

TermDefinition
Dental irrigation/aspiration syringeA hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from direct light

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
18006621202customerservice-ch@dentsplysirona.com
+41219212631info@pd-dental.com

Regulatory Flags

DUNS number
480420090
Device count
40
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
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

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