SERI
GUDID B6119467707
SERI Surgical Scaffold 15cm x 25cm
SOFREGEN MEDICAL INC.
Multi-purpose surgical mesh, silk, bioabsorbable| Primary Device ID | B6119467707 |
| NIH Device Record Key | 332bd499-ac7c-4183-88f8-4e395e0ee621 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SERI |
| Version Model Number | 94677 |
| Company DUNS | 079710838 |
| Company Name | SOFREGEN MEDICAL 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com | |
| Phone | 617 651 8871 |
| prodsurv@sofregen.com |
Device Dimensions
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B6119467707 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123128
FDA Product Code
| OXF | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-02 |
On-Brand Devices [SERI]
| B6119468001 | SERI Surgical Scaffold 10cm x 25cm |
| B6119467909 | SERI Surgical Scaffold 5cm x 15cm |
| B6119467808 | SERI Surgical Scaffold 20cm x 30cm |
| B6119467707 | SERI Surgical Scaffold 15cm x 25cm |
Trademark Results [SERI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SERI 90642523 not registered Live/Pending |
Lisa Canning 2021-04-13 |
 SERI 90066468 not registered Live/Pending |
Sustainable Electronics Recycling International 2020-07-22 |
 SERI 85612370 4314705 Live/Registered |
SOFREGEN MEDICAL IRELAND LIMITED 2012-04-30 |
 SERI 85294833 not registered Dead/Abandoned |
Seri Naturals (Pvt) Ltd. 2011-04-14 |
 SERI 77813716 not registered Dead/Abandoned |
ALLERGAN, INC. 2009-08-27 |
 SERI 77479270 3649631 Live/Registered |
SAVILLS INC. 2008-05-20 |
 SERI 73712605 1509883 Dead/Cancelled |
RUGBY LABORATORIES, INC. 1988-02-22 |
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