SERI Contour 95512

GUDID B611955121

SERI Contour Surgical Scaffold 10cm x 25cm

SOFREGEN MEDICAL INC.

Multi-purpose surgical mesh, silk, bioabsorbable
Primary Device IDB611955121
NIH Device Record Key4cbbc922-0130-4d4c-9def-9ca0023e1a15
Commercial Distribution StatusIn Commercial Distribution
Brand NameSERI Contour
Version Model Number95512
Catalog Number95512
Company DUNS079710838
Company NameSOFREGEN MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com
Phone617 651 8871
Emailprodsurv@sofregen.com

Device Dimensions

Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter
Width5 Centimeter
Length15 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB611955121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-08

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