Basis HI

GUDID 04582594041370

YAMAHACHI DENTAL MFG.,CO.

Dental appliance fabrication material, resin
Primary Device ID04582594041370
NIH Device Record Key562cfab0-48d6-4b11-8996-9e59bf334d89
Commercial Distribution StatusIn Commercial Distribution
Brand NameBasis HI
Version Model Number40g, LF α
Company DUNS693430001
Company NameYAMAHACHI DENTAL MFG.,CO.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104582594041370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-29
Device Publish Date2021-11-20

On-Brand Devices [Basis HI]

045822757104721kg, V PINK
045822757104103kg, O PINK
0458227571040340g, O PINK
045822757103971kg, O PINK
045825940413941kg, V PINK
0458259404138740g*25ml, LF α
0458259404137040g, LF α
0458259404136340g, LF PINK
0458259404135610kg, LF PINK
D080XXBHIX40GXXOPN040G,O PINK
D080XXBHIX40GXXLFP040G,LF PINK
D080XXBHIX40GXXLFA040G,LF α
D080XXBHIX3KGXXOPN03KG,O PINK
D080XXBHIX1KGXXVPN01KG,V PINK
D080XXBHIX1KGXXOPN01KG,O PINK
D080XXBHI10KGXXLFP010KG,LF PINK
D080XXBHIX40GXXVPN040G,V PINK
D080XXBHIX3KGXXVPN03KG,V PINK
D080XXBHIX3KGXXLFP03KG,LF PINK
D080XXBHIX3KGXXLFA03KG,LF α
D080XXBHIX1KGXXLFP01KG,LF PINK
D080XXBHIX1KGXXLFA01KG,LF α
D080XXBHI4020XXVPN040G*20ML,V PINK
D080XXBHI4020XXOPN040G*20ML,O PINK
D080XXBHI4020XXLFP040G*20ML,LF PINK
D080XXBHI4020XXLFA040G*20ML,LF α
D080XXBHI10KGXXVPN010KG,V PINK
D080XXBHI10KGXXOPN010KG,O PINK
D080XXBHI10KGXXLFA010KG,LF α
D080XXBHI100GXXVPN0100G,V PINK
D080XXBHI100GXXOPN0100G,O PINK
D080XXBHI100GXXLFP0100G,LF PINK
D080XXBHI100GXXLFA0100G,LF α

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