Gunze L T D

FDA Filings

This page includes the latest FDA filings for Gunze L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3010668881
FEI Number	3010668881
Name	GUNZE LIMITED
Owner & Operator	GUNZE LIMITED
Contact Address	46 Natsumegaichi, Aono Ayabe JP-26 Kyoto 623-8513 JP
Official Correspondent	Noriyuki Morikawa 81-773-428035-x
US Agent	Michael van der Woude Emergo Global Representation LLC 512 3279997 512 3279998 USAgent@ul.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	46 Natsumegaichi, Aono Ayabe Kyoto, 623-8513 JP
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04973077713783 GUNZE LIMITED	NEOVEIL NV-ET-M60L-3	2023-04-04
GUDID 04973077713776 GUNZE LIMITED	NEOVEIL NV-ET-M60E-3	2023-04-04
PMN K221487 Gunze Limited	NEOVEIL Staple Line Reinforcement	2022-08-26
PMN K213498 Gunze Limited	PELNAC Meshed Bilayer Wound Matrix	2022-07-14
PMN K213573 Gunze Limited	PELNAC Wound Matrix	2022-02-09
GUDID 04547301462558 GUNZE LIMITED	NEOVEIL NV-ET-M60E-2	2021-01-14
GUDID 04547301462534 GUNZE LIMITED	NEOVEIL NV-ET-M60A-2	2021-01-14
GUDID 04967162947221 GUNZE LIMITED	TheraGenesis Meshed Bilayer Wound Matrix TG-M8290	2020-09-22
GUDID 04967162947214 GUNZE LIMITED	TheraGenesis Meshed Bilayer Wound Matrix TG-M8260	2020-09-22
GUDID 04967162947207 GUNZE LIMITED	TheraGenesis Meshed Bilayer Wound Matrix TG-M82120	2020-09-22
GUDID 04967162947191 GUNZE LIMITED	TheraGenesis Meshed Bilayer Wound Matrix TG-M4060	2020-09-22
GUDID 04967162947184 GUNZE LIMITED	TheraGenesis Meshed Bilayer Wound Matrix TG-M4030	2020-09-22
GUDID 04967162947177 GUNZE LIMITED	TheraGenesis Meshed Bilayer Wound Matrix TG-M200240	2020-09-22
GUDID 04967162947160 GUNZE LIMITED	TheraGenesis Meshed Bilayer Wound Matrix TG-M120240	2020-09-22
GUDID 04967162947153 GUNZE LIMITED	TheraGenesis Bilayer Wound Matrix TG-B8290	2020-09-22
GUDID 04967162947146 GUNZE LIMITED	TheraGenesis Bilayer Wound Matrix TG-B8260	2020-09-22
GUDID 04967162947139 GUNZE LIMITED	TheraGenesis Bilayer Wound Matrix TG-B82120	2020-09-22
GUDID 04967162947122 GUNZE LIMITED	TheraGenesis Bilayer Wound Matrix TG-B4060	2020-09-22
GUDID 04967162947115 GUNZE LIMITED	TheraGenesis Bilayer Wound Matrix TG-B4030	2020-09-22
GUDID 04967162947108 GUNZE LIMITED	TheraGenesis Bilayer Wound Matrix TG-B200240	2020-09-22
GUDID 04967162947092 GUNZE LIMITED	TheraGenesis Bilayer Wound Matrix TG-B120240	2020-09-22
GUDID 04548366322481 GUNZE LIMITED	NEOVEIL NV-L-015G	2019-11-12
PMN K130997 \| OXC GUNZE LIMITED	NEOVEIL Tube/Sheet Type Suture and Staple Line Reinforcement Material	2014-01-13
PMN K130997 GUNZE LIMITED	NEOVEIL	2013-11-15

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091792460	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	142 BAG
2020091792460	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	142 BAG
2020091792460	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	142 BAG
2020091792460	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	142 BAG
2020091792460	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	142 BAG
2020091792460	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	142 BAG
2020091792460	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	142 BAG
2020091071347	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE	40 BAG
2020091071347	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	40 BAG
2020091071349	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE	80 BAG
2020091071349	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE	80 BAG
2020091071349	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE	80 BAG
2020091071349	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	80 BAG
2020090463813	Kobe,Japan -> Los Angeles, California	POLYESTER RESIN, STYRENE RESIN, POLYSTYRENE	78 PKG
2020082847159	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	80 BAG
2020082847159	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	80 BAG
2020082847159	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	80 BAG
2020082847159	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	80 BAG
2020082847701	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	60 BAG
2020082847701	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	60 BAG
2020082847701	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	60 BAG
2020082753617	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	80 BAG
2020082753617	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	80 BAG
2020082753617	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	80 BAG
2020082753617	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	80 BAG
2020082753650	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	60 BAG
2020082753650	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	60 BAG
2020082753650	Tokyo ,Japan -> Seattle, Washington	CLEAREN ---------------- STYRENE-BUTADIENE COPOLYMER	60 BAG