Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1211566

FEI Number

1211566

Entity Name

Ranfac Corp.

City/State/Country

Avon, MA, US

Establishment Address

30 DOHERTY AVE, Avon, MA 02322, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ranfac Corp. (Owner Number: 1211566)

Owner / Operator Contact Address

30 Doherty Ave., Avon, MA 02322, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK200543

PMA Number

N/A

All Registered Proprietary Names

RCBS RBN GSN RJN RTN CBMT BMET BMT CER-BN Centrifuge Bucket Sports Medicine Procedure Pack FATS Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack SS-1529 HYPODERMIC NEEDLE S-115 CONE BIOPSY NEEDLE TOUHY NEEDLE CONE VENTRICULAR NEEDLE RAN-11/10ccSyr.#2604-9002274192-01M; RAN-1115/10ccSyr.#2604-9002174193-01M; RAN-11N/10ccSyr.#2604-9002074194-01M RAD RAN BMAT RAN with Adjustable Guide Ranfac Bone Access Needle Access Needle Ranfac Access Needle CBN Blood Draw Kit RSG KPL DiscCath Needle Set CellXtract; Marrow Cellution Bone Marrow Aspiration Needle; MC-RAN; MAXX - REGEN Maxx-cell CER-ORTHO CER-LA CER-EXT CER-FLEX Accuport INJECTABLE BONE SUBSTITUTE DELIVERY CANNULA CER-SUB CER-SUB-83N ASK-1 - Aspiration Starter Kit IN-15 IN-12 RBS SBS SC-XCM Ranfac Bone Access Needle Access Needle Ranfac Access Needle LOCALIZER Injection Needle CER-RMR BONE CHIPPER and REAMER Ranfac Autologous Platelet Separator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2007-10-04
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2007-10-04
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2008-12-18
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2021-10-13
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	Class 2	878.5040	2015-12-22
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	1977-12-20
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	1977-12-20
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2013-12-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2014-11-17
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2017-04-19
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2019-07-01
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2019-07-01
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2008-12-18
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2008-12-18
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2021-09-27
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2015-06-12
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	1977-12-20
POZ	Biopsy Needle Kit	Gastroenterology, Urology	Class 2	876.1075	2018-12-13
FHO	Pneumoperitoneum Needle	Gastroenterology, Urology	Class 2	876.1500	2007-10-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-10-04
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2007-10-04
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2013-02-28
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-10-20
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1994-12-20
HTO	Reamer	Orthopedic	Class 1	888.4540	2021-02-02
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2021-04-13

Official Correspondent

Barry Zimble

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ranfac Corp.

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
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K904849	Origin Medsystems, Inc.	ORIGINEEDLE(TM)	1991-03-29
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
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-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-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1211566. Last updated year: 2026. Please use registration number 1211566 when referencing this establishment in official correspondence.