DuraSorb Monofilament Mesh

GUDID 00860000875943

SURGICAL INNOVATION ASSOCIATES, INC.

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• Primary Device ID: 00860000875943
• NIH Device Record Key: f76c857b-12b3-42bf-976c-91453888be43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraSorb Monofilament Mesh
• Version Model Number: PTM2025
• Company DUNS: 117061618
• Company Name: SURGICAL INNOVATION ASSOCIATES, 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: true
• 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: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health
• Phone: 872-870-0520
• Email: info@sia.health

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000875943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181094

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-22
• Device Publish Date: 2022-08-12

On-Brand Devices [DuraSorb Monofilament Mesh]

• 00860000875905: PTM1025
• 00860000875943: PTM2025
• 00860000875929: PTM0616