HySil Light

Primary DI
00814913024318
Brand
HySil Light
Company
HIOSSEN, INC.
Model
ESS50L
Device description
HySil Light [ 50㎖ x 4 ] Dental Impression Material
Published
2016-09-30
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
true

Related Records

Product Codes

CodeName
ELWMaterial, Impression

Product Code Classifications

CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00814913024318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00814913024318008149130243188149130243180814913024318

GMDN Terms

TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
796083090
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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