GalaFLEX CE0408

GUDID 00855920006591

GalaFLEX 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: 00855920006591
• NIH Device Record Key: fbe75635-e524-47b2-a8fa-d0bc2d361fa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GalaFLEX
• Version Model Number: 100035-36
• Catalog Number: CE0408
• 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

Device Dimensions

• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter
• Height: 10 Centimeter
• Length: 20 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855920006591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140533

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: 2020-04-17
• Device Publish Date: 2020-04-09

On-Brand Devices [GalaFLEX]

• 00855920006607: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006591: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006690: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006683: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006676: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006669: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006652: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006645: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006638: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006621: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006614: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006584: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006577: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate
• 00855920006560: GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate