Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019807891

FEI Number

3019807891

Entity Name

CENTERPIECE S. DE R.L DE C.V (sterilization site)

City/State/Country

Tijuana Baja California, MX

Establishment Address

Bulevar La Encantada Industrial, Parque Industrial El Florido, Seccion La Encantada #11530, Tijuana Baja California 22250, MX

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Centerpiece Holdings LLC (Owner Number: 10061801)

Owner / Operator Contact Address

420 Stevens Ave, Suite 230, Solana Beach, CA 92075, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Micro Therapeutics, Inc. ABBOTT BIOMET MANUFACTURING CORP Medtronic Perfusion Systems BIOMET MANUFACTURING CORP Medtronic, Inc. OSCOR CARIBE LLC Micro Therapeutics, Inc. HAEMONETICS CORPORATION OSCOR CARIBE LLC Merit Medical Systems, Inc. Devicor Medical Products, Inc HAEMONETICS CORPORATION Medtronic, Inc. Zimmer Biomet HAEMONETICS CORPORATION Medtronic Perfusion Systems HAEMONETICS CORPORATION Dexcom, Inc. Abbott Medical GreenSleeve Medical Corp MEDTRONIC VASCULAR OSCOR CARIBE LLC Merit Medical Systems, Inc. Merit Medical Systems, Inc. Devicor Medical Products, Inc. ContraHealth Ureteroscope Merit Medical Systems Inc. BIOMET INC Merit Medical Systems, Inc. Merit Medical Systems, Inc. ARTHROTEK, INC. BIOMET SPORTS MEDICINE OSCOR CARIBE LLC AXONICS, INC ABBOTT LABORATORIES Zimmer Biomet ARTHROTEK, INC. OSCOR CARIBE LLC OSCOR CARIBE LLC BIOMET INC BIOMET Inc. ELECTROMEDICS, INC. Merit Medical Systems, Inc. BIOMET MANUFACTURING, INC Medtronic Inc. ELECTROMEDICS, INC. INARI MEDICAL ELECTROMEDICS, INC. Devicor Medical Products, Inc. BIOMET SPORTS MEDICINE BIOMET INC Medtronic, Inc. Abbott Medical Merit Medical Systems, Inc. HAEMONETICS CORPORATION Abbott Vascular INARI MEDICAL BIOMET SPORTS MEDICINE HAEMONETICS CORPORATION MEDTRONIC BLOOD SYSTEMS, INC. BIOMET INC Devicor Medical Products, Inc INARI MEDICAL Medtronic Perfusion Systems OSCOR CARIBE LLC BIOMET INC HAEMONETICS CORPORATION BIOMET INC IRVINE BIOMEDICAL, INC. Medtronic, Inc. Care Fusion IRVINE BIOMEDICAL, INC. HAEMONETICS CORPORATION BIOMET SPORTS MEDICINE Merit Medical Systems, Inc. OSCOR CARIBE LLC BIOMET INC OSCOR CARIBE LLC Micro Therapeutics, Inc. (d/b/a ev3 Neurovascular) Abbot Medical Medtronic, Inc. Devicor Medical Products, Inc Medtronic Perfusion Systems INARI MEDICAL Medtronic Inc. AXONICS, INC EXTRACORPOREAL MEDICAL SPECIALITIES, INC. OSCOR CARIBE LLC Devicor Medical Products, Inc. CHESTNUT MEDICAL TECHNOLOGIES, INC. OSCOR CARIBE LLC Zimmer Biomet BIOMET INC Medtronic Inc. OSCOR CARIBE LLC MEDTRONIC BIO-MEDICUS, INC. HAEMONETICS CORPORATION Merit Medical Systems, Inc. HAEMONETICS CORPORATION HAEMONETICS CORPORATION Medtronic Perfusion Systems Merit Medical Systems, Inc. Medtronic Perfusion Systems INARI MEDICAL Abbott Medical Abbott Vascular

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2026-05-29
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2023-02-23
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4380	2023-02-23
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2023-02-23
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2023-02-23
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2023-02-23
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2023-02-23
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2023-02-23
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2023-06-21
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2023-06-21
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2023-06-21
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-06-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-05-20
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2026-05-29
LHG	Electrode, Spinal Epidural	Neurology	Class 2	882.5880	2026-05-29
OUT	Intracranial Aneurysm Flow Diverter	Unknown	Class 3	N/A	2026-03-06
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2025-12-17
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2026-05-29
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2026-05-29
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2026-05-29
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2026-05-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-04-21
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-04-28
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2025-12-17
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-03-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-12-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-17
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2025-12-17
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2025-06-24
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2025-12-17
QBJ	Integrated Continuous Glucose Monitoring System, Factory Calibrated	Clinical Chemistry	Class 2	862.1355	2024-07-12
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2025-12-11
OWQ	Reprocessed Intravascular Ultrasound Catheter	Cardiovascular	Class 2	870.1200	2025-12-11
MTD	Catheter, Intracardiac Mapping, High-Density Array	Cardiovascular	Class 2	870.1220	2025-12-11
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-12-11
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2022-11-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-10-10
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2026-05-29
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2026-05-29
FPK	Tubing, Fluid Delivery	General Hospital	Class 2	880.5440	2025-04-21
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2025-04-21
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-05-26
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-09-04
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2025-06-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2022-09-12
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2025-04-22
EXF	Bag, Bile Collecting	Gastroenterology, Urology	Class 2	876.5010	2025-04-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-06-21
DZL	Screw, Fixation, Intraosseous	Dental	Class 2	872.4880	2023-06-21
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2026-05-29
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2026-05-29
QON	Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	Gastroenterology, Urology	Class 3	876.5270	2023-12-14
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-11-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-12-17
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2023-06-21
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2023-06-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2026-05-29
PMP	Dorsal Root Ganglion Stimulator For Pain Relief	Unknown	Class 3	N/A	2026-05-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2024-05-20
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-05-20
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2025-06-24
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2025-08-06
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
DTP	Defoamer, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4230	2025-06-24
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2025-06-24
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2025-06-24
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-11-29
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2025-06-24
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-05-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-06-21
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2024-04-11
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2026-03-23
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-05-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2025-04-21
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2025-12-17
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2023-12-15
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2022-11-29
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2022-11-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2025-12-17
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2025-06-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-04-28
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2022-11-29
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4330	2025-06-24
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2026-05-29
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-06-21
KSW	System, Processing For Frozen Blood	Hematology	Class 2	864.9145	2025-12-17
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2022-11-29
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-05-20
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2026-02-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-11-29
KSW	System, Processing For Frozen Blood	Hematology	Class 2	864.9145	2025-12-17
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2021-06-04
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-06-21
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-06-21
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2025-04-22
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2026-05-29
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-04-11
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2026-05-29
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2023-03-27
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-03-27
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2023-03-27
NKM	Mitral Valve Repair Devices	Unknown	Class 3	N/A	2022-11-17
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2026-03-23
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2022-04-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-06-24
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2022-11-29
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2025-06-16
EZW	Stimulator, Electrical, Implantable, For Incontinence	Gastroenterology, Urology	Class 3	876.5270	2023-12-14
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2025-06-24
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2026-05-29
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-05-26
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2025-05-21
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2026-05-29
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2024-12-17
PHX	Shoulder Prosthesis, Reverse Configuration	Orthopedic	Class 2	888.3660	2023-06-21
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-06-21
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2025-06-24
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2026-05-29
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2025-06-24
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2025-12-17
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-04-21
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2025-12-17
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2025-12-17
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-06-24
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2025-04-21
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-06-24
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2022-11-17
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2022-11-04
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2022-11-17

Official Correspondent

JEFF HOVER

US Agent Details

Raza Mohammed Business: Global Director QA/RA Email: raza.mohammed@jcsaholdings.com Phone: (443) 5545486

Related Public Records

Same Entity

Centerpiece Holdings LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016096098	CENTERPIECE S. DE R.L DE C.V	Playas de Rosarito Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K823482	Intermedics Orthopedics	101 UNIVERSAL ENDOPROSTHESIS	1983-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019807891. Last updated year: 2026. Please use registration number 3019807891 when referencing this establishment in official correspondence.