FDA.report

Premium Plus

Primary DI
D83848668
Brand
Premium Plus
Company
Premium Plus International Limited
Model
4866
Device description
RUBBER DAM FRAME
Published
2020-01-07
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
false

Related Records

Product Codes

CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D83848668PackageHIBCC100In Commercial Distribution
D83848664PrimaryHIBCC0

GMDN Terms

TermDefinition
Rubber dam frameA flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusable device.

Sterilization Methods

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

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D8382288TP8Premium Plus2288TP2020-10-10
D8382288TW8Premium Plus2288TW2020-10-10
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D838FS2288P8Premium PlusFS2288P2020-10-10
D838FS2288W8Premium PlusFS2288W2020-10-10
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D8382288F48Premium Plus2288F42019-12-27
D8382288KID8Premium Plus2288KID2019-12-27
D8382288L18Premium Plus2288L12019-12-27
D8382288L28Premium Plus2288L22019-12-27
D8382288L38Premium Plus2288L32019-12-27

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