Directa Cheek Retractor 511583

GUDID 17310235115838

Directa AB

Hand-held dental retractor
Primary Device ID17310235115838
NIH Device Record Key2ddea10d-8adb-4e37-b0b1-a08ceaa402dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDirecta Cheek Retractor
Version Model NumberTranslucent Child
Catalog Number511583
Company DUNS353954381
Company NameDirecta AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117310235115838 [Primary]

FDA Product Code

EGZHolder, Film, X-Ray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

On-Brand Devices [Directa Cheek Retractor ]

17310235115821Translucent Adult
17310235115913Ivory Child
17310235115906Ivory Adult
17310235115890Clear Child
17310235115883Clear Adult
17310235115876Red Child
17310235115869Red Adult
17310235115852Blue Child
17310235115845Blue Adult
17310235115838Translucent Child

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