Seldin retractor Seldin

GUDID 00083208130014

Seldin retractor used to retract and protect soft tissue, to give better visualization and access a during surgery.

Suncoast Dental, Inc

Hand-held dental retractor
Primary Device ID00083208130014
NIH Device Record Keyac637abf-498c-433e-8b2b-47777d8705d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeldin retractor
Version Model NumberSeldin
Catalog NumberSeldin
Company DUNS078352849
Company NameSuncoast Dental, Inc
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone727-536-4880
Emailtatumcompliance@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100083208130014 [Primary]

FDA Product Code

EIGRetractor, All Types

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00083208130014]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-22
Device Publish Date2020-04-14

On-Brand Devices [Seldin retractor]

00083208130014Seldin retractor used to retract and protect soft tissue, to give better visualization and acce
00083208132032Seldin retractor used to retract and protect soft tissue, to give better visualization and acce
00083208132025Seldin retractor used to retract and protect soft tissue, to give better visualization and acce

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