GalaSHAPE 3D SH3D12
GUDID 00855920006393
GalaSHAPE 3D scaffold is a bioresorbable surgical mesh manufactured 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. The scaffold has a slight 3D curvature designed to promote better conformance with a patient's anatomy in locations in which a flat design does not easily conform. P4HB bioresorbs through a process of hydrolysis and hydrolytic enzymatic digestion. It has been developed to optimize resorption rate and prolong strength retention in order to provide support throughout the expected period of healing. Although the scaffold loses strength with time, its porous construction was designed to allow native tissue ingrowth and gradual transfer of load from the scaffold to the tissue. Pre-clinical implantation studies indicate that GalaSHAPE 3D scaffold retains approximately 70% of its strength at 12 weeks. Bioresorption of the scaffold material will be essentially complete within 18-24 months.
Tepha, Inc.
Multi-purpose surgical mesh, synthetic polymer, bioabsorbable| Primary Device ID | 00855920006393 |
| NIH Device Record Key | e1cc9ba5-3806-4a84-a79e-db56589bc5ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaSHAPE 3D |
| Version Model Number | 100042-12 |
| Catalog Number | SH3D12 |
| 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 |
Customer Support Contacts
Device Dimensions
| Width | 2.5 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
| Height | 10.2 Centimeter |
| Width | 2.5 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855920006393 [Primary] |
FDA Product Code
| OOD | Surgical Film |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00855920006393]
Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
[00855920006393]
Ethylene Oxide
[00855920006393]
Ethylene Oxide
[00855920006393]
Ethylene Oxide
[00855920006393]
Ethylene Oxide
[00855920006393]
Ethylene Oxide
[00855920006393]
Ethylene Oxide
[00855920006393]
Ethylene Oxide
[00855920006393]
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Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-02 |
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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