| Primary Device ID | 00810054980551 |
| NIH Device Record Key | d9c01575-f171-4d07-bce3-72c21bf3a6b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaFLEX LITE |
| Version Model Number | 100027-01 |
| Catalog Number | GFLT0515 |
| 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 |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Width | 15 Centimeter |
| Length | 5 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810054980551 [Primary] |
| OOD | Surgical Film |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-28 |
| Device Publish Date | 2021-07-20 |
| 00810054980575 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |
| 00810054980551 | GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybut |