RAYZir FS

GUDID 08800099968579

Vatech mcis Co., Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800099968579
NIH Device Record Keya356d152-6908-4a1a-8f12-ff24de3f3bbf
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAYZir FS
Version Model NumberFH C16 A4
Company DUNS688284886
Company NameVatech mcis Co., Ltd
Device Count5
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800099968579 [Unit of Use]
GS108800099969422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-30
Device Publish Date2024-04-22

On-Brand Devices [RAYZir FS]

08800099968845FH C16 D4M
08800099968838FH C16 D3M
08800099968821FH C16 D2M
08800099968814FH C16 C4M
08800099968807FH C16 C3M
08800099968791FH C16 C2M
08800099968784FH C16 C1M
08800099968777FH C16 B4M
08800099968760FH C16 B3M
08800099968753FH C16 B2M
08800099968746FH C16 B1M
08800099968739FH C16 A4M
08800099968722FH C16 A3.5M
08800099968715FH C16 A3M
08800099968708FH C16 A2M
08800099968692FH C16 A1M
08800099968685FH C16 D4
08800099968678FH C16 D3
08800099968661FH C16 D2
08800099968654FH C16 C4
08800099968647FH C16 C3
08800099968630FH C16 C2
08800099968623FH C16 C1
08800099968616FH C16 B4
08800099968609FH C16 B3
08800099968593FH C16 B2
08800099968586FH C16 B1
08800099968579FH C16 A4
08800099968562FH C16 A3.5
08800099968555FH C16 A3
08800099968548FH C16 A2
08800099968531FH C16 A1
08800099968524FH C14 D4M
08800099968517FH C14 D3M
08800099968500FH C14 D2M
08800099968494FH C14 C4M
08800099968487FH C14 C3M
08800099968470FH C14 C2M
08800099968463FH C14 C1M
08800099968456FH C14 B4M
08800099968449FH C14 B3M
08800099968432FH C14 B2M
08800099968425FH C14 B1M
08800099968418FH C14 A4M
08800099968401FH C14 A3.5M
08800099968395FH C14 A3M
08800099968388FH C14 A2M
08800099968371FH C14 A1M
08800099968364FH C14 D4
08800099968357FH C14 D3

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