GalaFLEX 3DR FR3D13
GUDID 00810054980117
GalaFLEX 3DR 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 | 00810054980117 |
| NIH Device Record Key | 716b6407-5c8b-4ea1-8712-1490f1c4c6f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaFLEX 3DR |
| Version Model Number | 100043-13 |
| Catalog Number | FR3D13 |
| 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
| 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 |
| 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 | 00810054980117 [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 | 2020-10-07 |
| Device Publish Date | 2020-09-29 |
On-Brand Devices [GalaFLEX 3DR]
| 00810054980254 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980247 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980230 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980223 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980216 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980209 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980193 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980186 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980179 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980162 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980155 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980148 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980131 | GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980124 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980117 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980100 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980094 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980087 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980070 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980063 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980056 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980049 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980032 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980025 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980018 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00810054980001 | GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
Trademark Results [GalaFLEX 3DR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALAFLEX 3DR 88632114 not registered Live/Pending |
Galatea Surgical, Inc. 2019-09-26 |
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