STRONGBITE PLUS REGULAR BODY

GUDID 08800024201498

Sherpakorea

Silicone dental impression material
Primary Device ID08800024201498
NIH Device Record Keye4a5614a-7f7a-455c-8102-11f7b81464b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTRONGBITE PLUS REGULAR BODY
Version Model NumberSTRONGBITE PLUS REGULAR BODY (50ml * 200 Cartridge
Company DUNS557822311
Company NameSherpakorea
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+827078429961
Emailhappidenco@naver.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800024201498 [Primary]

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-19
Device Publish Date2020-03-11

On-Brand Devices [STRONGBITE PLUS REGULAR BODY]

08800024201245STRONGBITE PLUS REGULAR BODY (50ml * 280 Cartridge
08800024201191STRONGBITE PLUS REGULAR BODY (50ml * 4 Cartridges)
08800024201498STRONGBITE PLUS REGULAR BODY (50ml * 200 Cartridge

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