Crosstex Surgical Masks with Secure Fit 2.0 Technology

GUDID 30732224005455

Procedural Secure Fit 2.0 Surgical Mask, Black

CROSSTEX INTERNATIONAL, INC.

Surgical/medical respirator, non-antimicrobial, single-use
Primary Device ID30732224005455
NIH Device Record Key70cb923f-b8da-4a96-b8a8-b301db55cc71
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrosstex Surgical Masks with Secure Fit 2.0 Technology
Version Model NumberGCPBKSF2
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count50
DM Exempttrue
Pre-market Exemptfalse
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 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
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224005454 [Unit of Use]
GS110732224005451 [Primary]
GS130732224005455 [Package]
Contains: 10732224005451
Package: [10 Units]
In Commercial Distribution
GS150732224005459 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FXXMask, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-13
Device Publish Date2023-01-20

On-Brand Devices [Crosstex Surgical Masks with Secure Fit 2.0 Technology]

30732224005455Procedural Secure Fit 2.0 Surgical Mask, Black
50732224005442Ultra with Secure Fit 2.0 Surgical Mask, Black

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