EISENHUT INSTRUMENTE GMBH

FDA Device Registration & Listing · FRITTLINGEN Baden-Wurttemberg, DE · Registration 8043507

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
8043507
FEI Number
3000041196
Entity Name
EISENHUT INSTRUMENTE GMBH
City/State/Country
FRITTLINGEN Baden-Wurttemberg, DE
Establishment Address
SCHILDECKSTR. 28-30, FRITTLINGEN Baden-Wurttemberg D-78665, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
EISENHUT INSTRUMENTE GMBH (Owner Number: 9002073)
Owner / Operator Contact Address
SCHILDECKSTR. 28-30, --, FRITTLINGEN, DE-BW D-78665, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 1998-07-14
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 1998-09-29
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-01-14
GAD Retractor General, Plastic Surgery Class 1 878.4800 1990-11-27
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 1990-11-27
KAK Probe, Ent Ear, Nose, Throat Class 1 874.4420 1998-10-01
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1992-01-14
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 1998-10-01
EMD Hemostat, Surgical Dental Class 1 872.4565 1990-11-27
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1998-09-29
EML Chisel, Bone, Surgical Dental Class 1 872.4565 1990-11-27
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 1992-01-14
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1998-09-29
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 1990-11-27
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1990-11-27
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1990-11-21
KTZ Caliper Orthopedic Class 1 888.4150 1997-05-28
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1998-10-01
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 1991-06-04
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 1998-09-29
KAW Punch, Antrum Ear, Nose, Throat Class 1 874.4420 1990-11-27
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1990-11-27

Official Correspondent

No official correspondent registered.

US Agent Details

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

Related Public Records

Same Entity

EISENHUT INSTRUMENTE GMBH
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
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19
K820290 The Anspach Effort, Inc. SELF RETAINING RETRACTOR FOR HAND SURG 1982-03-05
K760422 Cutter Laboratories, Inc. SURGICAL RETRACTOR 1976-08-23
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-2014 Aesculap, Inc. 1
UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0039-2018 Teleflex Medical 1
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number Establishment Name Location
9680424 BAERAMED INSTRUMENTE GMBH SCHWENNINGEN Baden-Wurttemberg, DE
9617426 PFAU MEDIZINISCHE INSTRUMENTE GMBH WANFRIED Hesse, DE
3004530184 ANDERSEN CALEDONIA LTD Bellshill Scotland, GB
3013358456 EMPIRE SURGICAL INSTRUMENTS COMPANY Sialkot Punjab, PK
1123010 TRINITY STERILE, INC. SALISBURY, MD, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043507. Last updated year: 2026. Please use registration number 8043507 when referencing this establishment in official correspondence.
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