FDA.reportPublic FDA data

SERI

Primary DI
B6119468001
Brand
SERI
Company
SOFREGEN MEDICAL INC.
Model
94679
Device description
SERI Surgical Scaffold 10cm x 25cm
Published
2018-03-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXFMesh, Surgical, Absorbable, Plastic And Reconstructive SurgeryGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123128000SERI SURGICAL SCAFFOLDAllergan2013-04-25OXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6119468001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, silk, bioabsorbableA sterile, bioabsorbable, multifilament knitted material made of silk intended to be implanted in the body to support or repair soft-tissue and/or to provide a temporary scaffold for tissue ingrowth. This non-dedicated device may be used in open or laparoscopic surgical procedures to provide immediate physical and mechanical stabilization. The silk fibres are derived from domesticated silkworms, processed to remove sericin, and is available as a flexible sheet that can be cut to the required shape/size. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter
Width5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
617 651 8871prodsurv@sofregen.com

Regulatory Flags#

DUNS number
079710838
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6119467707SERI946772018-03-02
B6119467808SERI946782018-03-02
B6119467909SERI946802018-03-02
B611955121SERI Contour95512955122018-03-08
B611SV1002SilkVoiceSV1002SV10022021-07-21
B611SV10021SilkVoiceSV1002SV10022021-07-21
B611SV2001SilkVoiceSV2001SV20012021-07-21
B611SV3001SilkVoiceSV3001SV30012021-07-21
B611SV30012SilkVoiceSV3001SV30012021-07-21
B611SV10011SilkVoiceSV1001SV10012020-08-07
B611SV1001SilkVoiceSV1001SV10012020-03-01
B611SV20011SilkVoiceSV2001SV20012020-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00733132644568GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644575GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644582GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644599GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644605GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644612GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644629GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644636GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644643GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644650GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644667GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644674GORE ENFORM Preperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644681GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644698GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644704GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644711GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
00733132644728GORE ENFORM Intraperitoneal BiomaterialW. L. Gore & Associates, Inc.OXF2018-09-28
B611955121SERI ContourSOFREGEN MEDICAL INC.OXF2018-03-08
B6119467707SERISOFREGEN MEDICAL INC.OXF2018-03-02
B6119467808SERISOFREGEN MEDICAL INC.OXF2018-03-02
B6119467909SERISOFREGEN MEDICAL INC.OXF2018-03-02
00733132605415GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OXF2017-02-13
00733132605422GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OXF2017-02-13
00733132605453GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OXF2017-02-13
00733132605439GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OXF2017-02-13
00733132605446GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OXF2017-02-13
00733132606139GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.OXF2017-02-13