FDA.report

5.4 Dual-Port Mixing Tips (50-pack)

Primary DI
07540172000703
Brand
5.4 Dual-Port Mixing Tips (50-pack)
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
033523
Catalog number
033523
Device description
Dental material mixing nozzle, non-sterile
Published
2020-10-21
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

Contact Domains

Product Codes

CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07540172000703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07540172000703075401720007037540172000703

GMDN Terms

TermDefinition
Dental material mixing nozzle, non-sterileA non-sterile device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Outer Diameter5.4Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)265-3444info@clinicianschoice.com

Regulatory Flags

DUNS number
626406016
Device count
1
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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