FDA.report

Premier

Primary DI
D6919007089
Brand
Premier
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9007089
Device description
Unit- Dose Syringe Dispenser
Published
2022-06-29
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

Product Codes

CodeName
KXRApplicator, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D6919007089PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental material cartridge-plunging applicator, single-componentA hand-held manual device intended to dispense a single-component dental material (not included) from a cartridge directly into the mouth; it is not intended to dispense more than one component simultaneously. It is typically a pistol-like device with a cartridge-plunging mechanism. This is a reusable device after appropriate cleaning.

Sterilization Methods

Method

Regulatory Flags

DUNS number
014789663
Device count
1
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
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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