Polysil Rigid BR

Primary DI
17540196000618
Brand
Polysil Rigid BR
Company
Scican Ltd
Model
SH-302
Catalog number
SH-302
Device description
Bite registraton material. Ideal for occlusion and other matrices (for all impression taking procedures requiring rigid, fast setting).
Published
2016-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540196000618PackageGS12In Commercial Distribution
07540196000611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754019600061817540196000618
07540196000611075401960006117540196000611

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at normal room temperature (65°-73°F / 18°-23°C).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18006677733tboyce@scican.com

Regulatory Flags#

DUNS number
204137145
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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07540196002462BRAVO G4 Chamber Autoclave7A6210307A6210302022-11-18
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07540196002486BRAVO G4 Chamber Autoclave7A6210107A6210102022-11-18
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07540196000444STATIM 5000 G4 Cassette AutoclaveG4-201103-RG4-201103-R2016-08-02
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