Traxodent - Itena 7007091

GUDID 00348783001006

Traxodent Value Pack - ITENA

PREMIER DENTAL PRODUCTS COMPANY

Gingival retraction solution
Primary Device ID00348783001006
NIH Device Record Key758d292d-e917-49dc-b8ce-30f18b36a8f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTraxodent - Itena
Version Model NumberTRAPACK-25
Catalog Number7007091
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100348783001006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVLCord, Retraction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-24
Device Publish Date2023-10-16

On-Brand Devices [Traxodent - Itena]

00348783001020Traxodent Trial (2 pack) - ITENA
00348783001013Traxodent Starter Pack - ITENA
00348783001006Traxodent Value Pack - ITENA

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