OWT

Product Code: OWT

Products Classified as OWT

5832

Mesh, Surgical, Absorbable, Abdominal Hernia

Surgical Mesh.

Total Product Life Cycle (TPLC) Devices

5832

Mesh, Surgical, Absorbable, Abdominal Hernia

Surgical Mesh.

Pre-market Notifications for OWT

K203267	The BioBrace Implant	Biorez, Inc.
K191773	GORE BIO-A Tissue Reinforcement	W.L. Gore & Associates, Inc.
K191749	TIGR Matrix Surgical Mesh, TIGR Surgical Mesh	Novus Scientific AB
K190185	Phasix ST Mesh With Open Positioning System	C.R. Bard, Inc.
K173143	Phasix ST Mesh	C. R. Bard Inc
K163005	TIGR Matrix Surgical Mesh	NOVUS SCIENTIFIC AB
K143380	Phasix ST Mesh	C. R. Bard Inc
K120728	PHASIX PLUG AND PATCH	C.R. BARD INC
K101287	TEPHAFLEX COMPOSITE MESH	TEPHA, INC.
K033671	GORE BIOABSORBABLE MESH	W. L. GORE & ASSOCIATES, INC.

Global Unique Device Identification Database

• 00733132644711: Mesh, Surgical, Absorbable, Abdominal Hernia
• 00733132644698: Mesh, Surgical, Absorbable, Abdominal Hernia
• 00733132644650: Mesh, Surgical, Absorbable, Abdominal Hernia
• 00733132644643: Mesh, Surgical, Absorbable, Abdominal Hernia
• 00733132644629: Mesh, Surgical, Absorbable, Abdominal Hernia
• 00733132644605: Mesh, Surgical, Absorbable, Abdominal Hernia
• 00733132644575: Mesh, Surgical, Absorbable, Abdominal Hernia
• 00733132644568: Mesh, Surgical, Absorbable, Abdominal Hernia
• 00733132606146: Mesh, surgical, absorbable, abdominal hernia
• 00733132606139: Mesh, surgical, absorbable, abdominal hernia
• 00733132605446: Mesh, surgical, absorbable, abdominal hernia
• H373FS080834: Mesh, surgical, absorbable, abdominal hernia
• 00801741095344: Mesh, surgical, absorbable, abdominal hernia
• 00801741095320: Mesh, surgical, absorbable, abdominal hernia
• 00801741095306: Mesh, surgical, absorbable, abdominal hernia

Maude Adverse Events

PHASIX ST W/ OPS	DAVOL INC., SUB. C.R. BARD, INC.	2020-03-23
GORE? BIO-A? HERNIA PLUG	W.L. GORE & ASSOCIATES	2020-02-11
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-31
UNKNOWN	W.L. GORE & ASSOCIATES	2019-11-26
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-11-07
UNKNOWN	W.L. GORE & ASSOCIATES	2019-11-06
UNKNOWN	W.L. GORE & ASSOCIATES	2019-11-06
GORE BIOABSORBABLE HERNIA PLUG	W.L. GORE & ASSOCIATES	2019-11-04
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-10-31
UNKNOWN	W.L. GORE & ASSOCIATES	2019-10-29
PHASIX ST	BARD SHANNON LIMITED 3005636544	2019-10-25
UNKNOWN	W.L. GORE & ASSOCIATES	2019-10-25
UNKNOWN	W.L. GORE & ASSOCIATES	2019-10-22
UNKNOWN	W.L. GORE & ASSOCIATES	2019-10-11
PHASIX ST	DAVOL INC., SUB. C.R. BARD, INC.	2019-10-11
PHASIX ST	DAVOL INC., SUB. C.R. BARD, INC.	2019-10-04
PHASIX ST	DAVOL INC., SUB. C.R. BARD, INC.	2019-10-01
PHASIX ST	DAVOL INC., SUB. C.R. BARD, INC.	2019-10-01
PHASIX ST	DAVOL INC., SUB. C.R. BARD, INC.	2019-10-01
UNKNOWN	W.L. GORE & ASSOCIATES	2019-09-30
UNKNOWN	W.L. GORE & ASSOCIATES	2019-09-25
PHASIX ST MESH	TEPHA, INC	2019-09-19
UNKNOWN	W.L. GORE & ASSOCIATES	2019-09-12
UNKNOWN	W.L. GORE & ASSOCIATES	2019-09-10
UNKNOWN	W.L. GORE & ASSOCIATES	2019-09-09
PHASIX ST	DAVOL INC., SUB. C.R. BARD, INC.	2019-09-04
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-08-29
UNKNOWN	W.L. GORE & ASSOCIATES	2019-08-27
UNKNOWN	W.L. GORE & ASSOCIATES	2019-08-21
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-08-15
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-08-05
PHASIX ST	DAVOL INC., SUB. C.R. BARD, INC.	2019-07-24
UNKNOWN	W.L. GORE & ASSOCIATES	2019-07-17
UNKNOWN	W.L. GORE & ASSOCIATES	2019-07-17
UNKNOWN	W.L. GORE & ASSOCIATES	2019-07-16
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-07-10
UNKNOWN	W.L. GORE & ASSOCIATES	2019-07-02
GORE DUALMESH? BIOMATERIAL	W.L. GORE & ASSOCIATES	2019-07-01
PHASIX ST	DAVOL INC., SUB. C.R. BARD, INC.	2019-06-18
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-06-18
UNKNOWN	W.L. GORE & ASSOCIATES	2019-06-12
UNKNOWN	W.L. GORE & ASSOCIATES	2019-06-12
GORE BIOABSORBABLE HERNIA PLUG	W.L. GORE & ASSOCIATES	2019-06-11
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-05-29
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-05-28
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-05-28
PHASIX ST MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-05-07
UNKNOWN	W.L. GORE & ASSOCIATES	2019-05-06
GORE? MYCROMESH? BIOMATERIAL	W.L. GORE & ASSOCIATES	2019-05-03
UNKNOWN	W.L. GORE & ASSOCIATES	2019-05-03