Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005579585

FEI Number

3005579585

Entity Name

KUNSTSTOFF CHRISTEL GMBH & CO. KG

City/State/Country

Bad Durrheim Baden-Wurttemberg, DE

Establishment Address

Carl-Friedrich-Benz-Strasse 6, Bad Durrheim Baden-Wurttemberg 78073, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kunststoff Christel GmbH & Co. KG (Owner Number: 10059058)

Owner / Operator Contact Address

Carl-Friedrich-Benz-Strasse 6, Bad Durrheim, DE-BW 78073, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Drill Guide OSSIO Staple - Size 25 Drill Guide OSSIO Staple - Size 15 Tamp OSSIO Staple - Size 25 Drill Guide OSSIO Staple - Size 20 Tamp OSSIO Staple - Size 15 OSSIOfiber Staple Inserter, Size 25 OSSIOfiber Staple Inserter, Size 15 Tamp OSSIO Staple - Size 20 OSSIOfiber Staple Inserter, Size 20 30160G6 Trokarhuelse, Groesse 6 mm 30108G6 Trokarhuelse, Groesse 13,5 mm 30160G5 Trokarhuelse, Groesse 6 mm 11603G5 Trokarhuelse, Groesse 2,5 mm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXJ	Staple Driver	Orthopedic	Class 1	888.4540	2026-02-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-03-13
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2026-02-05

Official Correspondent

Alexander Jauk

US Agent Details

Franz Menean Business: MEDAGENT, Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

Kunststoff Christel GmbH & Co. KG

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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

Similar Registrations

Registration Number	Establishment Name	Location
3008285983	L&K BIOMED CO.,LTD.	Yongin-SI Gyeonggi, KR
3013946322	NEXTCON INTERNATIONAL	Sialkot Punjab, PK
1054811	Sterigenics U.S. LLC	MULBERRY, FL, US
3014004349	Arthrex Singapore Pte Ltd.	Singapore Central Singapore, SG
3016727307	VIETMEDICAL DISTRIBUTION JOINT STOCK COMPANY	Hanoi Ha Noi, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005579585. Last updated year: 2026. Please use registration number 3005579585 when referencing this establishment in official correspondence.