CODMAN ETHISORB 831153

GUDID 10886704042709

CODMAN ETHISORB Dura Patch Polyglactin 910/poly-p-dioxanone 60mm x 140mm

CODMAN & SHURTLEFF, INC.

Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic Dura mater graft, synthetic

• Primary Device ID: 10886704042709
• NIH Device Record Key: 1e714245-b9aa-42b1-9a21-aa970a0583d5
• Commercial Distribution Discontinuation: 2022-09-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CODMAN ETHISORB
• Version Model Number: 83-1153
• Catalog Number: 831153
• Company DUNS: 607846297
• Company Name: CODMAN & SHURTLEFF, INC.
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 79 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704042709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991413

FDA Product Code

• GXQ: DURA SUBSTITUTE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-01-27
• Device Publish Date: 2015-09-20

On-Brand Devices [CODMAN ETHISORB]

• 10886704042709: CODMAN ETHISORB Dura Patch Polyglactin 910/poly-p-dioxanone 60mm x 140mm
• 10886704042693: CODMAN ETHISORB Dura Patch Polyglactin 910/poly-p-dioxanone 40mm x 60mm
• 10886704042686: CODMAN ETHISORB Dura Patch Polyglactin 910/poly-p-dioxanone 20mm x 30mm