X-Repair Z009

GUDID B055009

X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 43mm (WxL)

SYNTHASOME, INC.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable
Primary Device IDB055009
NIH Device Record Keyb2df17bd-ab64-41eb-a85c-ebbea7eb630a
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-Repair
Version Model NumberZ009
Catalog NumberZ009
Company DUNS140697280
Company NameSYNTHASOME, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx

Device Dimensions

Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter
Width25 Millimeter
Length43 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB055009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-03

On-Brand Devices [X-Repair]

B05500930X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 30mm (WxL)
B055009X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 43mm (WxL)
B05501035X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 35mm (WxL)
B05501030X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 30mm (WxL)
B055010X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 43mm (WxL)
B05500935X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 35mm (WxL)
B05500925X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 25mm (WxL)
B055008X-Repair, Bioabsorbable surgical mesh, double-layer 12mm x 43mm (WxL)

Trademark Results [X-Repair]

Mark Image

Registration | Serial
Company
Trademark
Application Date
X-REPAIR
X-REPAIR
78740382 3716984 Live/Registered
Synthasome, Inc.
2005-10-25

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