FDA.reportPublic FDA data

Polydioxanone/polyethylene suture

Definition
A multiple-strand (multifilament), synthetic thread made from strands of bioabsorbable polydioxanone and non-bioabsorbable polyethylene (PE), intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (includes use in orthopaedic surgeries). It is coated with a copolymer and may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device.
GUDID devices
44
Last updated
2022-11-23 07:58:03

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850046400018RENOVATIOBonago Medical Solutions LLCREN-TWIST-27-382022-11-15
00850046400025RENOVATIOBonago Medical Solutions LLCREN-TWIST-27-502022-11-15
00850046400032RENOVATIOBonago Medical Solutions LLCREN-TWIST-23-902022-11-15
00850046400049RENOVATIOBonago Medical Solutions LLCREN-TWIST-26-602022-11-15
00850046400056RENOVATIOBonago Medical Solutions LLCREN-PUSH-23-382022-11-15
00850046400063RENOVATIOBonago Medical Solutions LLCREN-MESH-19-382022-11-15
00850046400070RENOVATIOBonago Medical Solutions LLCREN-MESH-19-602022-11-15
00850046400087RENOVATIOBonago Medical Solutions LLCREN-RHIN-19-382022-11-15
00850046400094RENOVATIOBonago Medical Solutions LLCREN-RHIN-19-502022-11-15
00850046400100RENOVATIOBonago Medical Solutions LLCREN-SOFT-21-602022-11-15
00850046400117RENOVATIOBonago Medical Solutions LLCREN-SOFT-21-902022-11-15
00850046400124RENOVATIOBonago Medical Solutions LLCREN-HARP-21-602022-11-15
00850046400131RENOVATIOBonago Medical Solutions LLCREN-HARP-21-902022-11-15
00850046400148RENOVATIOBonago Medical Solutions LLCREN-HARP-19-1002022-11-15
00850046400155RENOVATIOBonago Medical Solutions LLCREN-HARP-19-602022-11-15
00850046400162RENOVATIOBonago Medical Solutions LLCREN-HARP-18-1002022-11-15
00850046400179RENOVATIOBonago Medical Solutions LLCREN-HARP-18-602022-11-15
00850046400193RENOVATIOBonago Medical Solutions LLCREN-DUAL-S2022-11-15
00850046400209RENOVATIOBonago Medical Solutions LLCREN-DUAL-W2022-11-15
00850046400216RENOVATIOBonago Medical Solutions LLCREN-HARP-18-100-12022-11-15
00850046400223RENOVATIOBonago Medical Solutions LLCREN-TSPRING-29-252022-11-15
00850046400230RENOVATIOBonago Medical Solutions LLCREN-T-SPRING-27-382022-11-15
00850046400247RENOVATIOBonago Medical Solutions LLCREN-T-SPRING-26-602022-11-15
00850046400186RENOVATIOBonago Medical Solutions LLCREN-HARP-18-802022-10-31
10850046400008RENOVATIOBonago Medical Solutions LLCREN-TWIST-29-252022-10-28
B772DWA1912MESHMEDYGLOBAL MEDICAL DEVICES SL.8X12021-06-07
B772DWA1913MESHMEDYGLOBAL MEDICAL DEVICES SL.8X12021-06-07
B772DWB1903SUPERTORNADO MEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-07
B772DWB2101SCREWCOGMEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-07
B772DWCB1912RHINOMEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-07
B772DWCB1913RHINOMEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-07
B772DWFB1801HARPOONMEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-07
B772DWFB1802HARPOONMEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-07
B772DWFB1901HARPOONMEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-07
B772DWFB1902HARPOONMEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-07
B772SC23G360TORNADOMEDYGLOBAL MEDICAL DEVICES SL.10x12021-06-07
B772SC23G390TORNADOMEDYGLOBAL MEDICAL DEVICES SL.10X12021-06-07
B772SC26G560TORNADOMEDYGLOBAL MEDICAL DEVICES SL.10x12021-06-07
B772SC27G538TORNADOMEDYGLOBAL MEDICAL DEVICES SL.10X12021-06-07
B772SC27G550TORNADOMEDYGLOBAL MEDICAL DEVICES SL.10x12021-06-07
B772SC29G625TORNADOMEDYGLOBAL MEDICAL DEVICES SL.10x12021-06-07
B772DWB2102SCREWCOGMEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-04
B772DWFB1803BOXMEDYGLOBAL MEDICAL DEVICES SL.20X12021-06-04
B772SS23G338TORNADOMEDYGLOBAL MEDICAL DEVICES SL.10x12021-06-04