OOD

Product Code: OOD

Products Classified as OOD

5819

Surgical Film

Surgical Mesh.

Total Product Life Cycle (TPLC) Devices

5819

Surgical Film

Surgical Mesh.

Pre-market Notifications for OOD

K202425	SurgiLattice Scaffold	Tepha, Inc.
K162922	GalaFORM 3D	TEPHA, INC.
K161424	Phasix Mesh	C.R. BARD INC.
K161092	GalaSHAPE 3D	Tepha, Inc.
K142818	Phasix Mesh	C.R. Bard
K140533	GALAFLEX MESH	TEPHA, INC.
K130326	TEPHAFLEX MELTBLOWN CONSTRUCT	TEPHA, INC.
K113721	TEPHAFLEX LIGHT MESH	TEPHA, INC.
K113723	TEPHAFLEX MESH	TEPHA, INC.
K111946	TEPHAFLEX MESH	TEPHA, INC.
K091633	TEPHAFLEX SURGICAL FILM	TEPHA, INC.
K070894	TEPHAFLEX SURGICAL MESH	TEPHA, INC.

Global Unique Device Identification Database

• 00363539020018: surgical film
• 00300090283018: surgical film
• 00801741107702: surgical film
• 00801741107696: surgical film
• 00801741107689: surgical film
• 00801741107672: surgical film
• 00801741107665: surgical film
• 00801741107658: surgical film
• 00801741107641: surgical film
• 00801741107634: surgical film
• 00801741107627: surgical film
• 00801741107610: surgical film
• 00801741107603: surgical film
• 00801741107597: surgical film
• 00801741107580: surgical film

Maude Adverse Events

GALAFORM	TEPHA, INC	2020-03-30
GALAFLEX	TEPHA, INC	2020-03-29
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-03-13
GALAFLEX	TEPHA, INC	2020-02-28
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-02-28
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-02-28
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-02-13
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-02-05
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-22
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-16
PHASIX FLAT MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-14
PHAISX FLAT MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-14
PHASIX FLAT MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-10
PHASIX FLAT MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-10
PHASIX FLAT MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-09
PHASIX FLAT MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-09
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-02
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2020-01-02
ALIGN? TO URETHRAL SUPPORT SYSTEM - HOOK + HALO	C.R. BARD, INC. (COVINGTON) -1018233	2019-11-01
PHASIX FLAT MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-10-24
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-09-12
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-09-04
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-07-10
GALASHAPE? 3D SCAFFOLD	TEPHA, INC	2019-07-08
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-06-24
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-05-28
PHASIX	DAVOL INC., SUB. C.R. BARD, INC.	2019-05-21
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-05-01
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-04-30
GALAFORM? SCAFFOLD 3D	TEPHA, INC	2019-03-22
GALAFLEX? SCAFFOLD	TEPHA, INC	2019-03-22
GALATEA (SPECIFIC PRODUCT INFORMATION NOT PROVIDED)	TEPHA, INC	2019-03-22
GALAFLEX? SCAFFOLD	TEPHA, INC	2019-03-14
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2019-03-07
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-12-11
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-12-04
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-11-05
PHASIX MESH	BARD SHANNON LIMITED -3005636544	2018-10-23
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-10-17
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-09-28
GALAFORM 3D	TEPHA, INC	2018-09-10
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-08-28
PHASIX	DAVOL INC., SUB. C.R. BARD, INC.	2018-08-21
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-07-16
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-06-26
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-06-19
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-06-11
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-06-08
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-05-22
PHASIX MESH	DAVOL INC., SUB. C.R. BARD, INC.	2018-04-19