Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017196117

FEI Number

3017196117

Entity Name

BRDH

City/State/Country

Roden Drenthe, NL

Establishment Address

Burgemeester van Wageningenlaan 35, Roden Drenthe 9301 BS, NL

Establishment Type(s)

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

Owner / Operator

BRDH (Owner Number: 10076038)

Owner / Operator Contact Address

Burgemeester van Wageningenlaan 35, Roden, NL-DR 9301 BS, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K984240

PMA Number

N/A

All Registered Proprietary Names

174006 176630 AR-8928BC-CP AR-1678-CP LF1837 Covidien LF1937 LF1923 EL5ML LS1020 LF1937 AR-1530BC 173022 00-8800-000-10 AR-7234 EGIA45AVM EGIAUSTND EGIA45AMT EGIA60AXT EGIA45AXT EGIA60AMT EGIA30AMT Endo Gia 30449 AR-2923PS AR-13995N AR-7237-7 AR-7237-7T AR-1204AS-90 TRIEEA31XT TRIEEA28MT ATS45 NS2013 GCS40G HARH36 HARH23 AR-2271 SIG45CTAVM SIG30CTAVM SIG45AXT SIG60AXT SIG30AMT SIG30AVM SIGTRS45AMT 72202467 72202468 212133 AR-2600SBS-5 212034 AR-1928SF-45 AR-1318FT-40 72205324 MSM20 C0R50 LF4418 HAR9F 176630 176647 AR-1318FT-40 AR-7200 72202674 HAR9F AR-9821 AR-1662BC-7 1665G SYM2015 ONB5STF2C AR-8400OBE AR-8400EX AR-8350DS AR-8926SS 5DCS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2021-03-28
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-03-28
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2022-04-03
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-04-03
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-02-05
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-03-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-07-06
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-02-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-19
NUJ	Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed	General, Plastic Surgery	Class 2	878.4400	2021-03-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-03-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-05-31
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2023-05-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-03-28
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2021-04-02
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-04-03
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-03-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-02
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-04-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2021-04-02
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-12
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-04-02
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-04-02
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2021-04-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-03-28
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2021-03-28
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-04-02
MNB	Device, Thermal Ablation, Endometrial	Unknown	Class 3	N/A	2021-03-28
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-04-19
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2021-03-28
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-11-12
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-03-28
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-19
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2021-04-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-04-02
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-02
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-02-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-02-05
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-04-02
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-02-05
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-02-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-02-05
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-04-02
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2021-04-02
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-06-17
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2022-02-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-04-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-03-28
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2021-04-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-03-28
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-06-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-11-12
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2021-04-02
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2021-04-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-02-05
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2022-02-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-02-05
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2022-12-19
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2022-12-19
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2022-12-19
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2022-12-19
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2022-12-19
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2022-12-19
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2022-12-19
OXJ	Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects	General, Plastic Surgery	Class 2	878.3300	2022-04-03
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2022-04-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-06-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-03-28
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-11-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-01

Official Correspondent

Maria Ubels

US Agent Details

Emily Matorin Business: FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

BRDH

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
K082659	Covidien Lp, Formerly Registered AS United States	MODIFIED ENDO STICH	2008-09-19
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
K130717	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RELOAD	2013-04-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0005-2021	N/A	2	Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - 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 3017196117. Last updated year: 2026. Please use registration number 3017196117 when referencing this establishment in official correspondence.