| Primary Device ID | 00855920006027 |
| NIH Device Record Key | 5c93d4fa-64fe-4d61-9fd7-41b7d7d2c08c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaFLEX Scaffold |
| Version Model Number | 100035-14 |
| Catalog Number | GP0208 |
| Company DUNS | 039856765 |
| Company Name | Tepha, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | 5 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| Length | 20 Centimeter |
| Width | 5 Centimeter |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00855920006027 [Primary] |
| OOD | Surgical Film |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
[00855920006027]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-27 |
| 00855920006133 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006126 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006119 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006102 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006096 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006089 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006072 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006065 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006058 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006041 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006034 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006027 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006010 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |
| 00855920006003 | GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4H |