Duo-Check Heat Sealing Sterilization Pouches SC411HS

GUDID 50732224109928

Compatible with steam and EO sterilization. With internal and external process indicators, 4 in x 11 in

CROSSTEX INTERNATIONAL, INC.

Sterilization packaging, single-use
Primary Device ID50732224109928
NIH Device Record Key313d2b18-8776-4bed-b78b-163b1b609081
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuo-Check Heat Sealing Sterilization Pouches
Version Model NumberSC411HS
Catalog NumberSC411HS
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count200
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Away from Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224109923 [Unit of Use]
GS110732224109920 [Primary]
GS150732224109928 [Package]
Contains: 10732224109920
Package: case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-18
Device Publish Date2023-08-10

On-Brand Devices [Duo-Check Heat Sealing Sterilization Pouches]

50732224109966Compatible with steam and EO sterilization. With internal and external process indicators, 10 in
50732224109959Compatible with steam and EO sterilization. With internal and external process indicators, 7 in
50732224109942Compatible with steam and EO sterilization. With internal and external process indicators, 6 in
50732224109935Compatible with steam and EO sterilization. With internal and external process indicators, 6 in
50732224109928Compatible with steam and EO sterilization. With internal and external process indicators, 4 in
50732224109911Compatible with steam and EO sterilization. With Internal and external process indicators, 4 in
50732224109904Compatible with steam and EO sterilization. With internal and external process indicators, 3 in

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