Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004076349

FEI Number

3004076349

Entity Name

PAJUNK MEDICAL SYSTEMS

City/State/Country

Alpharetta, GA, US

Establishment Address

4575 Marconi Dr., Alpharetta, GA 30005, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

PAJUNK GmbH Medizintechnologie (Owner Number: 8010639)

Owner / Operator Contact Address

Karl-Hall-Strasse 1, Geisingen, DE-BW 78187, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SPROTTE NRFit Kit Spinal anesthesia kit Nerve Block Tray Injection tube, anesthetic agent Sono MSK SPROTTE® NRFit kit EpiLong Soft NRFit Stim2Go Epidural anesthesia kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OFU	Spinal Anesthesia Kit	Anesthesiology	Class 2	868.5120	2016-10-24
OGJ	Nerve Block Tray	Anesthesiology	Class 2	868.5140	2017-12-05
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-03-13
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2025-07-02
OGD	Custom Anesthesia Tray	Anesthesiology	Class 2	868.5120	2016-11-07
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2024-01-10
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2024-01-10
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2024-01-10
HCC	Device, Biofeedback	Neurology	Class 2	882.5050	2024-01-10
OGE	Epidural Anesthesia Kit	Anesthesiology	Class 2	868.5120	2017-12-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PAJUNK GmbH Medizintechnologie

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9611612	PAJUNK GMBH MEDIZINTECHNOLOGIE	GEISINGEN Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0015-2012	Deroyal Industries, Inc. Lafollette	2	Custom anesthesia kits labeled as follows: (1) DeRoyal (R) Adult Exp Anesthesia Circuit, REF 86-001737, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Number 25660996 (2) DeRoyal (R) Adult Anesthesia Circuit, REF 86-001781, Rx Only, NON-STERILE, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Lot Numbers: 25574115, 25624514, 25661260, 25702578, 25766272, 25835901, 25835910, 25873406, 25906061, 25960681 (3) DeRoyal (R) Latex Safe Anesthesia Kit, REF 86-001641, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25573171, 25765667, 25834853, 25834861 (4) DeRoyal (R) Custom Anesthesia Kit, REF 86-001619, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Number 25573155 (5) DeRoyal (R) Anesthesia Kit, REF 86-001669, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Lot Numbers: 25313484, 25702324, 25977977 Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004076349. Last updated year: 2026. Please use registration number 3004076349 when referencing this establishment in official correspondence.