X-Repair Z010-30

GUDID B05501030

X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 30mm (WxL)

SYNTHASOME, INC.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device IDB05501030
NIH Device Record Key7d1e40f8-0f9d-4147-88fd-3f030b02d472
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-Repair
Version Model NumberZ010-30
Catalog NumberZ010-30
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
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com
Phone858-490-9400
Emailinfo@synthasome.com

Device Dimensions

Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter
Width40 Millimeter
Length30 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB05501030 [Primary]

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-01
Device Publish Date2023-07-24

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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