GalaFLEX LITE GFLT0022
GUDID 00810054980797
GalaFLEX LITE 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.
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable| Primary Device ID | 00810054980797 |
| NIH Device Record Key | 5ad1f186-6484-45db-be52-2b261f79e49c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaFLEX LITE |
| Version Model Number | 100027-33 |
| Catalog Number | GFLT0022 |
| 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 | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 Centimeter |
| Outer Diameter | 22 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 |
| 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 |
| 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 | 00810054980797 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113721
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 | 2023-08-03 |
| Device Publish Date | 2023-07-26 |
On-Brand Devices [GalaFLEX LITE]
| 00810054980636 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980629 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980612 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980605 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980599 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980582 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980568 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980544 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980827 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980810 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980803 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980797 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
Trademark Results [GalaFLEX LITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALAFLEX LITE 88639540 not registered Live/Pending |
Galatea Surgical, Inc. 2019-10-02 |
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