CODMAN ETHISORB 831153

GUDID 10886704042709

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

CODMAN & SHURTLEFF, INC.

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
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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
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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
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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
• 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
• 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
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

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