LUCKY STAR LRRADIATION SCIENCE CO.,LTD SHANGHAI

FDA Device Registration & Listing · Shanghai, CN · Registration 3009848807

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009848807
FEI Number
3009848807
Entity Name
LUCKY STAR LRRADIATION SCIENCE CO.,LTD SHANGHAI
City/State/Country
Shanghai, CN
Establishment Address
No.758Tianying Road,Qingpu Industrial Zone, Shanghai 201700, CN
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
Lucky Star lrradiation Science Co.,Ltd Shanghai (Owner Number: 10085638)
Owner / Operator Contact Address
No.758Tianying Road,Qingpu Industrial Zone, Shanghai, CN-SH 201700, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BZK Antiseptic Swab/Antiseptic Cleaning Wipes (Sting Free) Alcohol Cleaning pads; Alcohol prep pad; Antiseptic Povidone Iodine Prep Pad; easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use easyEndoTM Linear Cutting Stapler and Loading Units for Single Use easyCSTM Circular Stapler for Single Use; easyLCTM Linear Cutter Staplers and Loading Units for Single Use AMSure® Sterile Water, and Sterile Normal Saline for Wound Flush easyPPHTM Hemorrhoidal Stapler for Single Use

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRJ Disinfectant, Medical Devices General Hospital Class 1 880.6890 2023-06-25
GAG Stapler, Surgical General Hospital Class 2 878.4740 2024-01-22
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-01-22
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-01-22
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-01-22
FRO Dressing, Wound, Drug Unknown Class U N/A 2022-07-13
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2024-01-22
GAG Stapler, Surgical General Hospital Class 2 878.4740 2024-01-22

Official Correspondent

Tony Ye

US Agent Details

Roy Zhang Business: RGLM Consulting LLC Email: admin@rglm-fda.com Phone: (425) 2364274

Related Public Records

Same Entity

Lucky Star lrradiation Science Co.,Ltd Shanghai
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
K221629 Covidien Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) 2023-02-22
K231491 Covidien TA™ Stapler and Loading Unit with DST Series™ Technology 2023-08-16
K131563 Opus Ksd, Inc. SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM 2014-04-09
K131705 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY 2013-07-01
K103263 Covidien, Formerly US Surgical A Divison of Tyco H ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY 2010-11-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0070-2019 COVIDIEN LLC 2
EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.
Z-0001-2021 N/A 2
Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021 N/A 2
Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009848807. Last updated year: 2026. Please use registration number 3009848807 when referencing this establishment in official correspondence.
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