Home GUDID B055010 X-Repair
Primary DI B055010
Brand X-Repair
Company SYNTHASOME, INC.
Model Z010
Catalog number Z010
Device description X-Repair, Bioabsorbable surgical mesh, double-layer, 40mm x 43mm (WxL)
Published 2023-07-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FTL Mesh, Surgical, Polymeric OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FTL Mesh, Surgical, Polymeric General, Plastic Surgery 2 OWW Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B055010 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.
Device Sizes# Type, Value, Unit table Type Value Unit Length 43 Millimeter Width 40 Millimeter
Regulatory Flags# DUNS number 140697280 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B055008 X-Repair Z008 Z008 2023-07-24 B05500925 X-Repair Z009-25 Z009-25 2023-07-24 B05500935 X-Repair Z009-35 Z009-35 2023-07-24 B05501030 X-Repair Z010-30 Z010-30 2023-07-24 B05501035 X-Repair Z010-35 Z010-35 2023-07-24 B05502020 X-RepairSL Z020-20SL Z020-20SL 2023-07-24 B05502080 X-RepairSL Z020-80SL Z020-80SL 2023-07-24 B05502120 X-RepairSL Z021-20SL Z021-20SL 2023-07-24 B05502180 X-RepairSL Z021-80SL Z021-80SL 2023-07-24 B055009 X-Repair Z009 Z009 2016-10-03 B05500930 X-Repair Z009-30 Z009-30 2016-01-05 B055020160SL X-RepairSL Z020-160SL Z020-160SL 2017-02-13 B055021160SL X-RepairSL Z021-160SL Z021-160SL 2017-02-13 B05502280SL X-RepairSL Z022-80SL 2017-02-13 B05502480SL X-RepairSL Z024-80SL Z024-80SL 2017-02-13
Other Devices Sharing Product Codes# 
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