DISPOSABLE CSR WRAP ESW-8912

GUDID 10732224730797

Single use blue nonwoven sterilization wrap for packaging instrument trays and materials.

SPS Medical Supply Corp.

Sterilization packaging, single-use

• Primary Device ID: 10732224730797
• NIH Device Record Key: 1b0f9dd2-8c67-4c79-9d2b-b3fc34f8464d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPOSABLE CSR WRAP
• Version Model Number: ESW-8912
• Catalog Number: ESW-8912
• Company DUNS: 194877072
• Company Name: SPS Medical Supply Corp.
• Device Count: 1000
• DM Exempt: false
• Pre-market Exempt: false
• 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: true

Customer Support Contacts

• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com

Device Dimensions

• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch
• Length: 12 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Controlled room temperature per USP
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224730790 [Unit of Use]
GS1	10732224730797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062100

FDA Product Code

• FRG: Wrap, sterilization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-11-15

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• 10732224730797: Single use blue nonwoven sterilization wrap for packaging instrument trays and materials.