REFLECTYS CPTYS-B1

GUDID 03760260220217

ITENA CLINICAL

Dental composite resin
Primary Device ID03760260220217
NIH Device Record Key7c8f30d2-cc79-4f40-bc4c-a60f4a138885
Commercial Distribution StatusIn Commercial Distribution
Brand NameREFLECTYS
Version Model NumberB1 CP
Catalog NumberCPTYS-B1
Company DUNS278261221
Company NameITENA CLINICAL
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
GS103760260220217 [Primary]
GS103760260220439 [Unit of Use]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-11-10
Device Publish Date2016-10-15

On-Brand Devices [REFLECTYS]

03760260220316P CP
03760260220309I CP
03760260220293E CP
03760260220286A3O CP
03760260220279A2O CP
03760260220262D3 CP
03760260220255C3 CP
03760260220248C2 CP
03760260220231B3 CP
03760260220224B2 CP
03760260220217B1 CP
03760260220200A4 CP
03760260220194A3.5 CP
03760260220187A3 CP
03760260220170A2 CP
03760260220163A1 CP
03760260220156P
03760260220149I
03760260220132E
03760260220125A30
03760260220118A20
03760260220101D3
03760260220095C3
03760260220088C2
03760260220071B3
03760260220064B2
03760260220057B1
03760260220040A4
03760260220033A3.5
03760260220026A3
03760260220019A2
03760260220002A1

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