GalaFORM 3D FR3D14
GUDID 00855920006355
GalaFORM 3D scaffold is a bioresorbable surgical mesh manufactured 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. The scaffold has a 3D curvature supported with a P4HB rim designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue. Pre-clinical implantation studies indicate that GalaFORM 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months.
Tepha, Inc.
Multi-purpose surgical mesh, synthetic polymer, bioabsorbable| Primary Device ID | 00855920006355 |
| NIH Device Record Key | 218b6d35-9ba4-443e-81de-e4230c6f7d5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaFORM 3D |
| Version Model Number | 100043-14 |
| Catalog Number | FR3D14 |
| Company DUNS | 039856765 |
| Company Name | Tepha, 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 | 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
Device Dimensions
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855920006355 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162922
FDA Product Code
| OOD | Surgical Film |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00855920006355]
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Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-05-01 |
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 |
Trademark Results [GalaFORM 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALAFORM 3D 86663865 not registered Dead/Abandoned |
GALATEA SURGICAL, INC. 2015-06-16 |
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