GalaFORM 3D CEFR02
GUDID 00855920006713
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 | 00855920006713 |
| NIH Device Record Key | 46e66b97-b3ba-4080-b320-0cb00c3f850f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaFORM 3D |
| Version Model Number | 100043-22 |
| Catalog Number | CEFR02 |
| 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
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 |
| 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 | 00855920006713 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-26 |
| Device Publish Date | 2020-08-18 |
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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