FDA.report

Premium Plus

Primary DI
D8381145BLUE8
Brand
Premium Plus
Company
Premium Plus International Limited
Model
1145-BLUE
Device description
Face Shields
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
true

Related Records

Product Codes

CodeName
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Product Code Classifications

CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8381145BLUE8PackageHIBCC20In Commercial Distribution
D8381145BLUE4PrimaryHIBCC0

GMDN Terms

TermDefinition
Face splash shieldA clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.

Sterilization Methods

Method

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
false

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D8382288TB8Premium Plus2288TB2020-10-10
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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