Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010668881

FEI Number

3010668881

Entity Name

GUNZE LIMITED

City/State/Country

Ayabe Kyoto, JP

Establishment Address

46 Natsumegaichi, Aono, Ayabe Kyoto 623-8513, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUNZE LIMITED (Owner Number: 10045922)

Owner / Operator Contact Address

46 Natsumegaichi, Aono, Ayabe, JP-26 623-8513, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221487

PMA Number

N/A

All Registered Proprietary Names

NEOVEIL Staple Line Reinforcement

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	2022-09-19

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 LIMITED

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

View Entity Profile →

Similar Registrations

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3012481535	Teleflex Medical Inc.	Cincinnati, OH, US
3014272734	GMED Healthcare BVBA ( a Johnson & Johnson Company)	Courcelles Luxembourg, BE
3002294946	Johnson & Johnson MEDICAL GmbH	NORDERSTEDT Schleswig-Holstein, DE
3027419979	GUNZE MEDICAL LIMITED	Osaka, JP
3009380063	Medtronic Distribution Center	Memphis, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010668881. Last updated year: 2026. Please use registration number 3010668881 when referencing this establishment in official correspondence.