GalaFLEX 3D SH3D01
GUDID 00810054980261
GalaFLEX 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 | 00810054980261 |
| NIH Device Record Key | 58ddc25f-2b61-466d-8495-c0bc85fe5ff3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaFLEX 3D |
| Version Model Number | 100042-01 |
| Catalog Number | SH3D01 |
| 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
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
| Length | 15.5 Centimeter |
| Height | 5.3 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810054980261 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K161092
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 3D]
| 00810054980537 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980520 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980513 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980506 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980490 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980483 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980476 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980469 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980452 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980445 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980438 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980421 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980414 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980407 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980391 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980384 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980377 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980360 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980353 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980346 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980339 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980322 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980315 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980308 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980292 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980285 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980278 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
| 00810054980261 | GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyr |
Trademark Results [GalaFLEX 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALAFLEX 3D 88632099 not registered Live/Pending |
Galatea Surgical, Inc. 2019-09-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.