COE® 250112

GUDID 00386040001895

PERF SPACER MASTER 1EA 1D-22D

Gc America Inc.

Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use
Primary Device ID00386040001895
NIH Device Record Key61a33613-220b-44f2-8f83-3a998e93b977
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOE®
Version Model Number250112
Catalog Number250112
Company DUNS005473608
Company NameGc America Inc.
Device Count432
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100386040001895 [Unit of Use]
GS140386040001893 [Primary]

FDA Product Code

EBHMATERIAL, IMPRESSION TRAY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-28
Device Publish Date2023-04-20

On-Brand Devices [COE®]

D6585572021COEfect™ MinuteWipe Flow Pack
20386040012062COE® SPACER TRAYS #32D Anterior Perforated-Partial
40386040012059COE® SPACER TRAYS #31D Upper R, Lower L Perforated-Partial
20386040012048COE® SPACER TRAYS #30D Upper L, Lower R Perforated-Partial
20386040012031COE® SPACER TRAYS #22D Small Lower Perforated
40386040012028COE® SPACER TRAYS #21D Medium Lower Perforated
20386040012017COE® SPACER TRAYS #20D Large Lower Perforated
20386040012000COE® SPACER TRAYS Perforated Assorted Package
40386040011991COE® SPACER TRAYS #7D Small Upper Perforated
20386040011980COE® SPACER TRAYS #4D Medium Upper Perforated
40386040011977COE® SPACER TRAYS #1D Large Upper Perforated
10386040003209COE® Individual Extra Long Trays-Perforated #XL28 Lower
10386040003193COE® Individual Extra Long Trays-Perforated #XL24 Lower
10386040003186COE® Individual Extra Long Trays-Perforated #XL22 Lower
10386040003179COE® Individual Extra Long Trays-Perforated #XL21 Lower
10386040002264COE® Complete Denture-Perforated Individual #64 Upper
10386040002257COE® Complete Denture-Perforated Individual #63 Upper
10386040002240COE® Complete Denture-Perforated Individual #62 Upper
10386040002233COE® Complete Denture-Perforated Individual #61 Upper
10386040002226COE® Complete Denture - Perforated Set of 8 Contains 61, 62, 63, 64, 66, 67, 68, 69
10386040002219COE® McGowan-Winkler Denture -Perforated #48 Lower
10386040002202COE® McGowan-Winkler Denture-Perforated #47 Lower
10386040002196COE® McGowan-Winkler Denture-Perforated #46 Lower
10386040002189COE® McGowan-Winkler Denture-Perforated #45 Lower
10386040002172COE® McGowan-Winkler Denture-Perforated #44 Upper
10386040002165COE® McGowan-Winkler Denture-Perforated #43 Upper
10386040002158COE® McGowan-Winkler Denture-Perforated Individual #42 Upper
10386040002141COE® McGowan-Winkler Denture-Perforated Individual #41 Upper
10386040002134COE® McGowan-Winkler Denture-Perforated Set of 8
10386040002127COE® McGowan-Winkler Denture Perforated Individual #40 Upper XL
20386040002117COE® Partial-Perforated #33 Anterior Upper
20386040002100COE® Partial-Perforated Individual Tray, #32 Anterior Lower
40386040002098COE® Partial-Perforated Individual Tray, #31 Upper R, Lower L
10386040002080COE® Partial-Perforated Set of 4, Contais numbers: 30, 31, 32, 33
40386040002074COE® Partial-Perforated Individual Tray, #30 Upper L, Lower R
20386040002063COE® Pediatric Perforated Individual Tray, #24 Lower
20386040002056COE® Pediatric Perforated Individual Tray, #9 Upper
20386040002049COE® Pediatric-Perforated Individual Trays, #14 Upper
40386040002036COE® Pediatric Perforated Individual tray, #28 Lower
20386040002025COE® Regular-Perforated, Individual Tray, #7 Upper
10386040002011COE® Regular Perforated Trays set of 8, contains numbers 1, 3, 4, 5, 7, 20, 21, 22
10386040002004COE® Pediatric-Perforated Set of 6, Contains numbers 7, 9, 14, 22, 24, 28
10386040001854COE® Sideless Triple-Function Impression Trays, 50 trays
40386040000742COE® Regular-Perforated Individual tray, #22 Lower
40386040000735COE® Regular-Perforated, Individual Tray, #21 Lower
40386040000728COE® Regular-Perforated, Individual Trays, #20 Lower
20386040000717COE® Regular-Perforated, Individual Tray, #5 Upper
40386040000681COE® Regular-Perforated Individual tray, #1 Upper XL
20386040003114COE® Check-Bite™ #72, Unilateral, Non-Water Cooled
20386040003107COE® Check-Bite™ #70, Unilateral, Water Cooled, for Hydrocolloid

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.