Dental Dams

GUDID 50732224002243

Dental Dam, Unflavored, 6" x 6", Natural Latex, Heavy

CROSSTEX INTERNATIONAL, INC.

Rubber dam, Hevea-latex
Primary Device ID50732224002243
NIH Device Record Key11fd587b-5896-43f2-a251-ae66762d438b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDental Dams
Version Model Number19301
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count36
DM Exempttrue
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224002248 [Unit of Use]
GS110732224002245 [Primary]
GS150732224002243 [Package]
Contains: 10732224002245
Package: [40 Units]
In Commercial Distribution

FDA Product Code

EIEDAM, RUBBER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-07
Device Publish Date2022-09-29

On-Brand Devices [Dental Dams]

50732224002243Dental Dam, Unflavored, 6" x 6", Natural Latex, Heavy
50732224002236Dental Dam, Unflavored, 6" x 6", Natural Latex, Medium
50732224002229Dental Dam, Unflavored, 6" x 6", Natural Latex, Thin
50732224002212Dental Dam, Peppermint Flavored, 6" x 6", Medium
50732224002205Dental Dam, Mint Flavored, 6" x 6", Natural Latex, Heavy
50732224002199Dental Dam, Mint Flavored, 6" x 6", Natural Latex, Medium
50732224002182Dental Dam, Mint Flavored, 6" x 6", Natural Latex, Thin
50732224002175Dental Dam Natural Latex, Unflavored, 5" x 5", Heavy
50732224002168Dental Dams, Natural Latex, Unflavored 5" x 5", Medium
50732224002151Dental Dam Natural Latex, Unflavored, 5" x 5" Thin
50732224002144Dental Dam Natural Latex, Mint, 5" x 5", Heavy
50732224002137Dental Dam Natural Latex, Mint, 5" x 5", Medium
50732224002120Dental Dam Natural Latex, Mint, 5" x 5", Thin
50732224005640Dental Dam, Non-Latex, Peppermint, 6" x 6",Medium, Light Blue
50732224005633Dental Dam, Natural Latex, Unflavored, 6" x 6", Thin Black
50732224005626Dental Dam, Natural Latex, Unflavored, 6" x 6", Heavy Black
50732224005619Dental Dam, Natural Latex, Unflavored, 6" x 6", Medium, Black
50732224005602Dental Dam, Natural Latex, Unflavored, 5" x 5", Thin Black
50732224005596Dental Dam, Natural Latex, Unflavored, 5" x 5", Heavy Black
50732224005589Dental Dam, Natural Latex, Unflavored, 5" x 5", Medium, Black

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