Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027419979

FEI Number

3027419979

Entity Name

GUNZE MEDICAL LIMITED

City/State/Country

Osaka, JP

Establishment Address

5F, JRE Dojima Tower, 2-4-27, Dojima, Kita-ku, Osaka 5300003, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

GUNZE MEDICAL LIMITED (Owner Number: 10088147)

Owner / Operator Contact Address

15F, Tokyo Shiodome Bldg., 1-9-1, Higashi-Shinbashi,, Minato-ku, JP-13 1057315, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130997

PMA Number

N/A

All Registered Proprietary Names

NEOVEIL Staple Line Reinforcement TheraGenesis Non-Meshed Bilayer Wound Matrix TheraGenesis Meshed Bilayer Wound Matrix NEOVEIL Sheet Type Suture and Staple Line Reinforcement Material; NEOVEIL Tube Type Staple Line Reinforcement Material

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2023-06-01
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2023-06-01
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2023-06-01
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2023-06-01

Official Correspondent

Aya Mikami

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

GUNZE MEDICAL LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

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3002294946	Johnson & Johnson MEDICAL GmbH	NORDERSTEDT Schleswig-Holstein, DE
3009380063	Medtronic Distribution Center	Memphis, TN, US
3011137372	Teleflex Medical LLC	Morrisville, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027419979. Last updated year: 2026. Please use registration number 3027419979 when referencing this establishment in official correspondence.