X-Repair Z010

GUDID B055010

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Primary Device ID	B055010
NIH Device Record Key	babb7cf8-5da5-48dd-91d3-9c4df7c3e5de
Commercial Distribution Status	In Commercial Distribution
Brand Name	X-Repair
Version Model Number	Z010
Catalog Number	Z010
Company DUNS	140697280
Company Name	SYNTHASOME, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B055010 [Primary]

OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

Steralize Prior To Use	false
Device Is Sterile	true

B05500930	X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 30mm (WxL)
B055009	X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 43mm (WxL)
B05501035	X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 35mm (WxL)
B05501030	X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 30mm (WxL)
B055010	X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 43mm (WxL)
B05500935	X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 35mm (WxL)
B05500925	X-Repair, Bioabsorbable surgical mesh, double-layer, 25mm x 25mm (WxL)
B055008	X-Repair, Bioabsorbable surgical mesh, double-layer 12mm x 43mm (WxL)

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