FDA.report

Premium Plus

Primary DI
D838705558
Brand
Premium Plus
Company
Premium Plus International Limited
Model
7055
Device description
Disposable dynamic mixing tips
Published
2020-01-08
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
JDZMixer, Cement, For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D838705558PackageHIBCC25In Commercial Distribution
D838705554PrimaryHIBCC0
D83870550Unit of UseHIBCC0

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
668367758
Device count
48
DM exempt
true
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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D8382288TG8Premium Plus2288TG2020-10-10
D8382288TL8Premium Plus2288TL2020-10-10
D8382288TP8Premium Plus2288TP2020-10-10
D8382288TW8Premium Plus2288TW2020-10-10
D838FS2288B8Premium PlusFS2288B2020-10-10
D838FS2288G8Premium PlusFS2288G2020-10-10
D838FS2288L8Premium PlusFS2288L2020-10-10
D838FS2288P8Premium PlusFS2288P2020-10-10
D838FS2288W8Premium PlusFS2288W2020-10-10
D8382288F18Premium Plus2288F12019-12-27
D8382288F28Premium Plus2288F22019-12-27
D8382288F38Premium Plus2288F32019-12-27
D8382288F48Premium Plus2288F42019-12-27
D8382288KID8Premium Plus2288KID2019-12-27
D8382288L18Premium Plus2288L12019-12-27
D8382288L28Premium Plus2288L22019-12-27
D8382288L38Premium Plus2288L32019-12-27

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25060238201791MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
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08058964728753Arthrex Bone Cement Closed Mixing Bowl G21 SRLJDZ2024-10-14
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