Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1056553

FEI Number

1000132370

Entity Name

REMINGTON MEDICAL, INC.

City/State/Country

ALPHARETTA, GA, US

Establishment Address

6830 Meadowridge Ct, ALPHARETTA, GA 30005, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

REMINGTON MEDICAL, INC. (Owner Number: 9006473)

Owner / Operator Contact Address

6830 MEADOWRIDGE CT., --, Alpharetta, GA 30005, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

10cc Locking Syringe LNGC-14 LNGO-2022 LNGC-2022 Aspiration and Injection Needles Remington Medical Chiba Needle Marked SafeOp 3: Neural Informatix System Graft Delivery Sleeves and Caps, Sterile Kit Breast Localization Needle TendoNova Ocelot TDS 1000 Bionix Internal Feeding Tube Declogger McKesson Internal Feeding Tube Declogger NAC Automatic Cutting Needles VascuChek Surgical Probe DRAINAGE BAG (600-D) Family Adapter Cap VascuChek Transceiver VascuChek Clinical Probe VascuChek Charger VascuChek Kit VascuChek System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2026-01-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-28
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2007-12-20
IZH	System, X-Ray, Mammographic	Radiology	Class 2	892.1710	2007-11-09
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2026-01-28
BSK	Cuff, Tracheal Tube, Inflatable	Anesthesiology	Class 2	868.5750	2026-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-02-04
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2019-02-04
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2020-04-22
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2007-11-09
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2018-11-20
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-11-20
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-11-20
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2018-11-20
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-11-20
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2018-11-20
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2018-11-20
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2018-11-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-11-20
FST	Light, Surgical, Fiberoptic	General, Plastic Surgery	Class 2	878.4580	2026-01-28
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2007-11-09
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2024-05-22
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2024-05-22
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2024-05-22
GXZ	Electrode, Needle	Neurology	Class 2	882.1350	2024-05-22
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2024-05-22
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2024-05-22
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-02-19
MIJ	Needle, Tumor Localization	General, Plastic Surgery	Class 1	878.4800	2007-11-09
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2015-11-10
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2013-02-19
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2022-09-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2014-11-17
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2006-02-28
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2014-11-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2014-11-17
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2014-11-17
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2023-04-04
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2022-12-13
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2026-01-28
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2007-11-21
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-03-05
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2022-02-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-01-28
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2013-03-11
DTA	Tester, Pacemaker Electrode Function	Cardiovascular	Class 2	870.3720	2013-03-11
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2026-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-28
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2026-01-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2026-01-28
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2022-12-16
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2022-12-16
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-12-16
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2022-12-16
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2022-12-16
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-12-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-12-16
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-12-16
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2022-12-16
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2019-09-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2013-02-19
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2018-04-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-04-03
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2018-04-03
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2015-06-10
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2006-02-28
ORZ	Eyelid Thermal Pulsation System	Ophthalmic	Class 2	886.5200	2017-01-20
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2014-11-17
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2014-11-17
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2014-11-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2026-01-28
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2014-12-08
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2014-02-25
PDQ	Neurosurgical Nerve Locator	Ear, Nose, Throat	Class 2	874.1820	2017-08-01
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2025-06-27
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2026-01-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-01-28
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2026-01-28
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2026-01-28
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2021-10-12
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2013-02-19
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2013-02-19
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2013-02-19
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-02-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

REMINGTON MEDICAL, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009265194	Remington Medical, S.A.	Santo Domingo Este, DO
3007014520	Remington Medical, Inc.	Alpharetta, GA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
Z-0006-2014	H & H Associates	2	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part *H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708*. The product is used to maintain fracture alignment.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1056553. Last updated year: 2026. Please use registration number 1056553 when referencing this establishment in official correspondence.