NYLON SELF-SEAL POUCH NSP-405

GUDID 00732224733616

For use with dry heat sterilization processes up to 420°F, 3" x 10"

CROSSTEX INTERNATIONAL, INC.

Sterilization packaging, single-use
Primary Device ID00732224733616
NIH Device Record Keya475102a-96c3-4ff3-82f8-f2f7adffaac3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNYLON SELF-SEAL POUCH
Version Model NumberNSP-405
Catalog NumberNSP-405
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count100
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 Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
Storage Environment HumidityBetween 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 22 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224733616 [Unit of Use]
GS110732224733613 [Primary]

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 Date2023-09-25
Device Publish Date2023-09-15

On-Brand Devices [NYLON SELF-SEAL POUCH]

00732224733647For use with dry heat sterilization processes up to 420°F, 9.5" x 13"
00732224733630For use with dry heat sterilization processes up to 420°F, 7" x 10.5"
00732224733623For use with dry heat sterilization processes up to 420°F, 4" x 10"
00732224733616For use with dry heat sterilization processes up to 420°F, 3" x 10"

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