GalaFORM 3D CEFR01

GUDID 00855920006706

GalaFORM 3D 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: 00855920006706
• NIH Device Record Key: 6c27c82b-9274-4363-a5e4-90d4a0452f4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GalaFORM 3D
• Version Model Number: 100043-21
• Catalog Number: CEFR01
• 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: 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: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter
• Width: 15.5 Centimeter
• Height: 5.3 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855920006706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162922

FDA Product Code

• OOD: Surgical Film

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-10-21
• Device Publish Date: 2020-06-10

On-Brand Devices [GalaFORM 3D]

• 00855920006355: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006348: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006331: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006324: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006317: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006300: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006287: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006270: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006263: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006256: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006249: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006232: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006225: GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (
• 00855920006829: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006812: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006805: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006799: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006782: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006775: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006768: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006751: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006744: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006737: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006720: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006713: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr
• 00855920006706: GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr