GalaFLEX CE0208
GUDID 00855920006584
GalaFLEX 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 | 00855920006584 |
| NIH Device Record Key | 1a8f5dd4-ea3a-4c65-8a40-0d8efd73401d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaFLEX |
| Version Model Number | 100035-35 |
| Catalog Number | CE0208 |
| 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
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
| Height | 5 Centimeter |
| Length | 20 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855920006584 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140533
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 | 2020-08-26 |
| Device Publish Date | 2020-08-18 |
On-Brand Devices [GalaFLEX]
| 00855920006607 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006591 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006690 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006683 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006676 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006669 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006652 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006645 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006638 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006621 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006614 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006584 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006577 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
| 00855920006560 | GalaFLEX scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate |
Trademark Results [GalaFLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALAFLEX 85273670 4301942 Live/Registered |
GALATEA SURGICAL, INC. 2011-03-22 |
 GALAFLEX 85197843 not registered Dead/Abandoned |
GENOMMA LAB INTERNACIONAL, S.A.B. DE C.V. 2010-12-14 |
 GALAFLEX 72143407 0748771 Dead/Expired |
KIEFER K. G. 1962-04-30 |
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