Premium Plus

Primary DI
D838N050MIXB8
Brand
Premium Plus
Company
Premium Plus International Limited
Model
N050MIXB
Device description
Bur Dispenser
Published
2020-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D838N050MIXB8PackageHIBCC100In Commercial Distribution
D838N050MIXB2PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer/disinfector rack instrument-holding insert, reusableA device intended to be fitted into the rack/container/tray of a sterilizer or disinfector to hold, position, and sometimes protect a medical/surgical instrument(s) during a sterilization and/or disinfection procedure. It may be available in various forms including a plug-like cone with a hollow centre for instrument placement. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
668367758
Device count
1
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D83848982Premium Plus48982020-01-08
D8384604Premium Plus4602019-12-27
D8384704Premium Plus4702019-12-27
D8387460B4Premium Plus7460-B2019-12-27
D8387460G4Premium Plus7460-G2019-12-27
D8387460L4Premium Plus7460-L2019-12-27
D8387460R4Premium Plus7460-R2019-12-27
D8387460Y4Premium Plus7460-Y2019-12-27
D8387470B4Premium Plus7470-B2019-12-27
D8387470G4Premium Plus7470-G2019-12-27
D8387470L4Premium Plus7470-L2019-12-27
D8387470R4Premium Plus7470-R2019-12-27
D8387470Y4Premium Plus7470-Y2019-12-27
D8389062Premium Plus9062019-12-26
D8389072Premium Plus9072019-12-26
D83832202Premium Plus32202020-01-08
D83832252Premium Plus32252020-01-08
D838033LBLUE2Premium Plus033-LBLUE2020-01-08
D8381140BEIGE2Premium Plus1140-BEIGE2020-01-07
D8381140BLUE2Premium Plus1140-BLUE2020-01-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
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