X-Repair Z009-35

GUDID B05500935

X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 35mm (WxL)

SYNTHASOME, INC.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device IDB05500935
NIH Device Record Keyae8d8f4d-42ad-43d4-a4ff-3fa0feb51381
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-Repair
Version Model NumberZ009-35
Catalog NumberZ009-35
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

Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter
Length35 Millimeter
Width25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB05500935 [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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