Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1064858

FEI Number

3008397795

Entity Name

ANDERSEN SCIENTIFIC, INC.

City/State/Country

Morrisville, NC, US

Establishment Address

1001 Aviation Parkway, Suite 600, Morrisville, NC 27560, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

ANDERSEN SCIENTIFIC, INC. (Owner Number: 9034670)

Owner / Operator Contact Address

1001 Aviation Parkway, Suite 600, Morrisville, NC 27560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CORE Shoulder System AccuPoint Electrode TracLux Aventus Thrombectomy System Stainless Steel Distraction Screw Orchid Safety Release Valve OSPREY Midline Closed IV Catheter System Radical the Dude 7F Guide Catheter Radical 7F Access Catheter BNLE Access Guidewire PUMA-G NPWT Prevent Kit Distraction screw iWand HEMIGARD Interlock OSPREY Closed IV Catheter System Optimotion Blue Knee System Aventus Thrombectomy System Radical 8F Access Catheter Radical the Dude 8F Guide Catheter IOPS Fiducial Tracking Pad IOPS Viewpoint Double Curve Catheter IOPS Guidewire Handle IOPS Guidewire 2 . IOPS Viewpoint Simple Curve Catheter Tactix Vector Suture Kit Aventus Thrombectomy System Luminelle DTx Hysteroscopy System BioBrace(R) PinXel-RF TalWire Access Guidewire Withrow Sialendoscopy Schaitkin Salivary Hemorrhage Occluder Pin Hemorrhage Occluder Pin with Applicator Orthotin TMJ Replacement Symmetric Total Knee Augments Orchid Safety Release Valve Profusion Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2022-03-08
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2026-03-19
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-04-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2025-05-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-12-30
GZL	Electrode, Depth	Neurology	Class 2	882.1330	2018-11-28
FSZ	Light, Surgical, Carrier	General, Plastic Surgery	Class 2	878.4580	2026-03-18
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2026-03-18
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-03-18
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2012-12-11
QOI	Intravenous Catheter Force-Activated Separation Device.	General Hospital	Class 2	880.5220	2026-03-18
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-03-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-03-18
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2026-03-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-08-07
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-03-18
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-05-19
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2023-05-19
QLY	Ophthalmic Syringe	General Hospital	Class 2	880.5860	2023-05-19
KGC	Tube, Gastro-Enterostomy	Gastroenterology, Urology	Class 2	876.5980	2026-03-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2023-05-19
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-03-18
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2026-03-18
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2026-03-18
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-04-29
QOI	Intravenous Catheter Force-Activated Separation Device.	General Hospital	Class 2	880.5220	2023-05-19
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2022-03-08
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2026-03-18
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2026-03-18
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2023-05-19
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2026-03-19
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2026-03-19
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2026-03-19
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2023-05-19
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-05-19
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3670	2023-05-19
QHE	Shoulder Arthroplasty Implantation System	Orthopedic	Class 2	888.3660	2023-05-19
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-03-18
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2026-03-18
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2026-03-18
OMD	Cutaneous Tissue Adhesive With Mesh	General, Plastic Surgery	Class 2	878.4011	2022-03-08
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-03-18
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2026-03-18
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-04-29
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2026-03-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-03-18
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2026-03-18
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2026-03-19
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-03-18
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2026-03-18
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-04-29
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-11-28
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-11-28
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Neurology	Class 2	882.5330	2020-12-30
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2020-12-30
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2026-03-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2026-03-18
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2026-03-18
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2026-03-18
JDQ	Cerclage, Fixation	Orthopedic	Class 2	888.3010	2021-04-29
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2026-03-18
OUH	Skin Resurfacing Rf Applicator	General, Plastic Surgery	Class 2	878.4400	2018-11-28
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2026-03-18
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-08-07
PMS	Peripheral Intravenous (Piv) Infiltration Monitor	General Hospital	Class 2	880.5725	2022-03-08
OAJ	Catheter, Drainage, Intraoral/Extraoral	General, Plastic Surgery	Class 1	878.4200	2026-03-18
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-04-29
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2026-03-18
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3530	2021-04-29
LZD	Joint, Temporomandibular, Implant	Dental	Class 3	872.3940	2026-03-18
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2026-03-23
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2021-04-29
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2021-04-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2021-04-29
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2021-04-29
QOI	Intravenous Catheter Force-Activated Separation Device.	General Hospital	Class 2	880.5220	2026-03-18
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2018-11-29

Official Correspondent

DARYL WOODMAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANDERSEN SCIENTIFIC, INC.

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

View Entity Profile →

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Related Recall Records

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Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1064858. Last updated year: 2026. Please use registration number 1064858 when referencing this establishment in official correspondence.