FDA.report

DIA-100SS

Primary DI
08806383500524
Brand
DIA-100SS
Company
DiaDent Group International
Model
Regular Set_Blue
Catalog number
1005-5024
Device description
Dia-100SS are developed for face and eyes protection from flying debris and other harmful substances.
Published
2020-08-14
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
false

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
08806383500524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08806383500524088063835005248806383500524

GMDN Terms

TermDefinition
Face splash shield, reusableA 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 reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00* Keep Dry and away from Sunlight.

Sterilization Methods

Method

Regulatory Flags

DUNS number
687789453
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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06944835173383DIA-X FILE25mm D1571-S2012026-02-20
06944835173390DIA-X FILE25mm D2571-S2022026-02-20
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06944835173413DIA-X FILE25mm D4571-S2042026-02-20
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