GalaSHAPE 3D CESH13
GUDID 00855920006546
GalaSHAPE 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 | 00855920006546 |
| NIH Device Record Key | 27f3a596-db28-4a06-b46c-9c979ae94625 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaSHAPE 3D |
| Version Model Number | 100042-33 |
| Catalog Number | CESH13 |
| 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 | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
| Outer Diameter | 7.6 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855920006546 [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 | 2020-08-26 |
| Device Publish Date | 2020-08-18 |
On-Brand Devices [GalaSHAPE 3D]
| 00855920006416 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006409 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006393 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006386 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006379 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006362 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006218 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006201 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006195 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006188 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006171 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006164 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006157 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006140 | GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate |
| 00855920006461 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006447 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006423 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006553 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006546 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006539 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006522 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006515 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006508 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006492 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006485 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006478 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006454 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
| 00855920006430 | GalaSHAPE 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybuty |
Trademark Results [GalaSHAPE 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALASHAPE 3D 86953182 not registered Dead/Abandoned |
Galatea Surgical, Inc. 2016-03-25 |
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