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 ID: 00732224733616
• NIH Device Record Key: a475102a-96c3-4ff3-82f8-f2f7adffaac3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NYLON SELF-SEAL POUCH
• Version Model Number: NSP-405
• Catalog Number: NSP-405
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 100
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0130
• Email: regulatoryaffairs@hu-friedy.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze. Keep away from sunlight, sterilants and excessive heat.
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 22 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224733616 [Unit of Use]
GS1	10732224733613 [Primary]

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-25
• Device Publish Date: 2023-09-15

On-Brand Devices [NYLON SELF-SEAL POUCH]

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