FDA.reportPublic FDA data

Multi-purpose surgical mesh, collagen, bioabsorbable

Definition
A sterile, bioabsorbable, flat or three-dimensional (3-D) implantable material made from animal-derived collagen intended for multiple tissue defect repair/hernia reduction (e.g., inguinal, ventral/incisional, umbilical, femoral) applications including an extra-abdominal application(s) [e.g., plastic surgery, breast reconstruction]. It may also be used as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.
GUDID devices
382
Last updated
2022-03-31 08:16:40

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00827002125810BiodesignCOOK BIOTECH INCORPORATEDG125812015-11-03
00827002349773BiodesignCOOK BIOTECH INCORPORATEDG349772015-11-03
00827002349780BiodesignCOOK BIOTECH INCORPORATEDG349782015-11-03
00827002349797BiodesignCOOK BIOTECH INCORPORATEDG349792015-11-03
00827002349803BiodesignCOOK BIOTECH INCORPORATEDG349802015-11-03
00827002528659BiodesignCOOK BIOTECH INCORPORATEDG528652015-11-03
09421906017748Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDSR05LG2020US2022-03-23
00827002528673BiodesignCOOK BIOTECH INCORPORATEDG528672015-11-03
00827002528666BiodesignCOOK BIOTECH INCORPORATEDG528662015-11-03
10827002515793Biodesign AdditaeCOOK BIOTECH INCORPORATEDG515792021-11-16
10827002592879Biodesign AdditaeCOOK BIOTECH INCORPORATEDG592872021-11-16
05694310961721Kerecis® Omega3 SurgiBindKERECIS hf.4x7cm Solid SurgiBind2021-10-11
05694310961745Kerecis® Omega3 SurgiBindKERECIS hf.7x10cm Solid SurgiBind2021-10-11
05694310961769Kerecis® Omega3 SurgiBindKERECIS hf.7x20cm Solid SurgiBind2021-10-11
05694310961783Kerecis® Omega3 SurgiBindKERECIS hf.4x7cm Fenestrated SurgiBind2021-10-11
05694310961806Kerecis® Omega3 SurgiBindKERECIS hf.7x10cm Fenestrated SurgiBind2021-10-11
05694310961820Kerecis® Omega3 SurgiBindKERECIS hf.7x20cm Fenestrated SurgiBind2021-10-11
05694310961844Kerecis® Omega3 SurgiBindKERECIS hf.3x7cm Solid SurgiBind2021-10-11
05694310961868Kerecis® Omega3 SurgiBindKERECIS hf.3x12cm Solid SurgiBind2021-10-11
05694310961882Kerecis® Omega3 SurgiBindKERECIS hf.250cm2 Solid SurgiBind2021-10-11
05694310961905Kerecis® Omega3 SurgiBindKERECIS hf.300cm2 Solid SurgiBind2021-10-11
05694310961929Kerecis® Omega3 SurgiBindKERECIS hf.3x7cm Fenestrated SurgiBind2021-10-11
05694310961943Kerecis® Omega3 SurgiBindKERECIS hf.3x12cm Fenestrated SurgiBind2021-10-11
05694310961967Kerecis® Omega3 SurgiBindKERECIS hf.250cm2 Fenestrated SurgiBind2021-10-11
05694310961981Kerecis® Omega3 SurgiBindKERECIS hf.300cm2 Fenestrated SurgiBind2021-10-11
10827002128481BiodesignCOOK BIOTECH INCORPORATEDG128482015-11-03
10827002131160BiodesignCOOK BIOTECH INCORPORATEDG131162015-11-03
10827002138060BiodesignCOOK BIOTECH INCORPORATEDG138062015-11-03
10827002138077BiodesignCOOK BIOTECH INCORPORATEDG138072015-11-03
10827002138084BiodesignCOOK BIOTECH INCORPORATEDG138082015-11-03
09421906017601Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDSR05LG1020US2021-08-12
09421906017618Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDSR05LG1010US2021-08-12
09421906017625Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDSR05LG0505US2021-08-12
09421906017632Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDSR03LG1020US2021-08-12
09421906017649Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDSR03LG1010US2021-08-12
09421906017656Myriad Matrix™ Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDSR03LG0505US2021-08-12
09421904065215OviTex® CoreAROA BIOSURGERY LIMITEDF10254-0408G2016-09-24
09421904065222OviTex® CoreAROA BIOSURGERY LIMITEDF10254-0610G2016-09-24
09421904065239OviTex® CoreAROA BIOSURGERY LIMITEDF10254-1012G2016-09-24
09421904065253OviTex® CoreAROA BIOSURGERY LIMITEDF10254-1620G2016-09-24
09421904065260OviTex® CoreAROA BIOSURGERY LIMITEDF10254-1822G2016-09-24
09421904065277OviTex® CoreAROA BIOSURGERY LIMITEDF10254-2020G2016-09-24
09421904065284OviTex® 1SAROA BIOSURGERY LIMITEDF10256-0408G2016-09-24
09421904065291OviTex® 1SAROA BIOSURGERY LIMITEDF10256-0610G2016-09-24
09421904065307OviTex® 1SAROA BIOSURGERY LIMITEDF10256-1012G2016-09-24
09421904065314OviTex® 1SAROA BIOSURGERY LIMITEDF10256-1020G2016-09-24
09421904065321OviTex® 1SAROA BIOSURGERY LIMITEDF10256-1620G2016-09-24
09421904065338OviTex® 1SAROA BIOSURGERY LIMITEDF10256-1822G2016-09-24
09421904065345OviTex® 1SAROA BIOSURGERY LIMITEDF10256-2020G2016-09-24
09421904065352OviTex® 2SAROA BIOSURGERY LIMITEDF10258-0408G2016-09-24
09421904065369OviTex® 2SAROA BIOSURGERY LIMITEDF10258-0610G2016-09-24
09421904065376OviTex® 2SAROA BIOSURGERY LIMITEDF10258-1012G2016-09-24
09421904065383OviTex® 2SAROA BIOSURGERY LIMITEDF10258-1020G2016-09-24
09421904065390OviTex® 2SAROA BIOSURGERY LIMITEDF10258-1620G2016-09-24
09421904065406OviTex® 2SAROA BIOSURGERY LIMITEDF10258-1822G2016-09-24
09421904065413OviTex® 2SAROA BIOSURGERY LIMITEDF10258-2020G2016-09-24
00860006566708BioBrace 5mmBiorez, Inc.BB5X2502021-05-24
00860006566715BioBrace 23mmBiorez, Inc.BB23X302021-05-24
M26330060010Meso Bilayer Surgical MeshDSM BIOMEDICAL, INC.30060-012015-09-15
M26330060020Meso BIlayer Surgical MeshDSM BIOMEDICAL, INC.30060-022015-09-15
M26330060030Meso Bilayer Surgical Mesh DSM BIOMEDICAL, INC.30060-032015-09-15
M26330060040Meso BIlayer Surgical Mesh DSM BIOMEDICAL, INC.30060-042015-09-15
M26330060050Meso Bilayer Surgical Mesh DSM BIOMEDICAL, INC.30060-052015-09-15
M26330060060Meso BIlayer Surgical MeshDSM BIOMEDICAL, INC.30060-062015-09-15
10827002590592FortifyCOOK BIOTECH INCORPORATEDG590592021-05-07
10827002590608FortifyCOOK BIOTECH INCORPORATEDG590602021-05-07
10827002590615FortifyCOOK BIOTECH INCORPORATEDG590612021-05-07
10827002590622FortifyCOOK BIOTECH INCORPORATEDG590622021-05-07
10827002590639FortifyCOOK BIOTECH INCORPORATEDG590632021-05-07
10827002590646FortifyCOOK BIOTECH INCORPORATEDG590642021-05-07
10827002590653FortifyCOOK BIOTECH INCORPORATEDG590652021-05-07
10827002590660FortifyCOOK BIOTECH INCORPORATEDG590662021-05-07
M32803140060Strattice Reconstructive Tissue Matrix BPSLIFECELL CORPORATION03140062015-09-17
M32804160060Strattice Reconstructive Tissue Matrix BPSLIFECELL CORPORATION04160062015-09-17
M32805160010Strattice Reconstructive Tissue MatrixLIFECELL CORPORATION05160012015-09-17
M32806060020Strattice Reconstructive Tissue MatrixLIFECELL CORPORATION06060022015-09-17
M32806080010Strattice Reconstructive Tissue MatrixLIFECELL CORPORATION06080012015-09-17
M32806080050Strattice Reconstructive Tissue Matrix LaparoscopicLIFECELL CORPORATION06080052015-09-17
M32806100080Strattice Reconstructive Tissue MatrixLIFECELL CORPORATION06100082015-09-17
M32806130090Strattice Reconstructive Tissue MatrixLIFECELL CORPORATION06130092015-09-17