Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014527916

FEI Number

3014527916

Entity Name

SYNCHRONIS MEDICAL LLC

City/State/Country

Romulus, MI, US

Establishment Address

11501 Metro Airport Center drive, Suite 100, Romulus, MI 48174, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Synchronis Medical LLC (Owner Number: 10057093)

Owner / Operator Contact Address

11501 Airport Metro Airport Center Drive, Suite 100, Romulus, MI 48174, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IV Start Kit Chemotherapy spill clean-up kit Chest Valve / Chest Valve Kits Synchronis Underpad Blood specimen collection convenience kit Forward Field Cricothyrotomy Kit Field Chest Tube Insertion Kit with Halo Seal GAX - TOURNIQUET, NONPNEUMATIC Field Minor Surgery Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRS	I.V. Start Kit	General Hospital	Class 2	880.5200	2020-03-25
PWT	Chemotherapy Spill Clean-Up Kit	General Hospital	Class 1	880.6250	2025-12-31
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2020-06-24
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2026-01-12
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2025-04-11
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2019-01-29
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-05-01
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2026-01-12
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2026-01-12
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2025-12-31
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2026-01-12
FME	Gown, Examination	General Hospital	Class 1	880.6265	2018-02-21
OGP	Cricothyrotomy Kit	Anesthesiology	Class 2	868.5800	2020-03-26
PYI	Thoracic Catheter Insertion Tray	General, Plastic Surgery	Class 1	878.4200	2020-03-26
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2019-06-05
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2020-03-25
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2019-03-29

Official Correspondent

Richard Hardman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Synchronis Medical LLC

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.

Similar Registrations

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2521402	B. BRAUN MEDICAL INC.	BETHLEHEM, PA, US
2029015	Sterigenics U.S., LLC	Ontario, CA, US
1061124	Sterigenics U.S., LLC	Charlotte, NC, US
1423395	MEDLINE INDUSTRIES, LP - SPT	Waukegan, IL, US
3005595283	MEDLINE INDUSTRIES, LP - Laredo	LAREDO, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014527916. Last updated year: 2026. Please use registration number 3014527916 when referencing this establishment in official correspondence.