FDA.report

HYJET DISP A/W SYRINGE TIPS 150/bag WHITE

Primary DI
D77824552500
Brand
HYJET DISP A/W SYRINGE TIPS 150/bag WHITE
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
245-5250
Catalog number
245-5250
Device description
HYJET DISP A/W SYRINGE TIPS 150/bag WHITE
Published
2021-02-27
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
ECBUNIT, SYRINGE, AIR AND/OR WATER

Product Code Classifications

CodeDeviceSpecialtyClass
ECBUnit, Syringe, Air And/Or WaterDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D77824552501PrimaryHIBCC0
D77824552500Unit of UseHIBCC0

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)901-3368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
150
DM exempt
true
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
false
Sterilization required before use
false

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