GalaFLEX LITE GFLT1020

GUDID 00810054980575

GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.

Tepha, Inc.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 00810054980575
• NIH Device Record Key: 73134bdb-9d48-477f-8515-4fa8862d76ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GalaFLEX LITE
• Version Model Number: 100027-15
• Catalog Number: GFLT1020
• Company DUNS: 039856765
• Company Name: Tepha, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 7813571750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com
• Phone: 781-357-1750
• Email: contact@galateasurgical.com

Device Dimensions

• Width: 10 Centimeter
• Length: 20 Centimeter
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Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810054980575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113721

FDA Product Code

• OOD: Surgical Film

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: 2021-07-28
• Device Publish Date: 2021-07-20

On-Brand Devices [GalaFLEX LITE]

• 00810054980575: GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut
• 00810054980551: GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut