AceConnex™ PSF141100-5

GUDID 00810053078679

AceConne™ Pre-Sutured Fascia

ALLOSOURCE

Cadaveric-donor fascia allograft

• Primary Device ID: 00810053078679
• NIH Device Record Key: b7000c97-a8ba-4a95-b199-b7bddbdc54bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AceConnex™
• Version Model Number: PSF141100-5
• Catalog Number: PSF141100-5
• Company DUNS: 946808136
• Company Name: ALLOSOURCE
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter
• Length: 100 Millimeter
• Outer Diameter: 5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and -40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810053078679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213046

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

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: 2023-11-16
• Device Publish Date: 2023-11-08

On-Brand Devices [AceConnex™]

• 00810053078709: AceConnex™ Pre-Sutured Fascia
• 00810053078693: AceConnex™ Pre-Sutured Fascia
• 00810053078686: AceConnex™ Pre-Sutured Fascia
• 00810053078679: AceConne™ Pre-Sutured Fascia
• 00810053078662: AceConnex™ Pre-Sutured Fascia
• 00810053078655: AceConnex™ Pre-Sutured Fascia