Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009656988

FEI Number

3009656988

Entity Name

STERIPACK USA (LIMITED) LLC

City/State/Country

Lakeland, FL, US

Establishment Address

4255 S Pipkin Rd, Lakeland, FL 33811, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SteriPack USA (Limited) LLC (Owner Number: 10044297)

Owner / Operator Contact Address

4255 South Pipkin Road, Lakeland, FL 33811, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nasal Specimen Collection Materials SteriPack Sterile Polyester Spun Swab and Swab in Tube Sterile Flocked Swab Sterile Foam Swab Invia Foam Dressing Kit ClarifEye Markers Semi Automatic Biopsy Gun For Invivo Philips Fully Automatic Biopsy Gun for Invivo Philips Needle Block for Invivo Biopsy Device Grid dS Breast CRYOVIAL; Saliva Collection Aid (SCA) Grid Immobilization Plate BBC for Invivo Breast Biopsy Coil Needle Hub Assembly for Invivo Breast Biopsy Pillar System Pillar Immobilization Plate BBC for Invivo Breast Biopsy Coil Pillar Immobilization Plate for Invivo LBS Mammotome Device Pillar Immobilization Plate BBC for Invivio Mammotome Device Grid Immobilization Plate LBS M-L for Invivo Breast Biopsy System LBS Pillar Immobilization Plate LBS C-C for Invivo Breats Biopsy System LBS Fiducial Holder for Invivo BBC Mammotome Device Needle Block Holder for Invivo Breast Biopsy Grid System Pillar Immobilization Plate LBS M-L for Invivo Biopsy System LBS Grid Immobilization Plate LBS C-C for Invivo Breast Biopsy System LBS Leloc Tumor Localizer Biopsy Grid Plate Enteral Feeding MRI Needle Block for Invivo Biopsy Device Needle Sleeve for Invivo Biopsy Device Aspiration Biopsy MRI UriCap Family; UriCap- Female M; UriCap-Female L Puracol Ultra Powder ACTABOND Topical Skin Adhesive Invia Foam Dressing Kit ClipLoc Localization Needle UroNav Sensor Clips ELECTRODE, CUTANEOUS Semi Automatic Biopsy Gun UVL1500 UVLrx Console; UVL1510 Patient Cable; UVL1520 Dry Light Adapter Contact Nipple Shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2022-02-18
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-06-03
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-06-26
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2020-10-29
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2019-05-07
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-05-28
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2024-03-20
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2019-08-16
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2020-12-28
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2018-05-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-03-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-03-20
MIG	Strip, Test Isoniazid	Unknown	Class U	N/A	2019-07-19
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2019-07-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2019-06-26
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2018-05-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-03-20
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2019-07-22
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Gastroenterology, Urology	Class 1	876.5250	2021-11-23
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2020-02-25
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2017-02-10
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-06-26
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-07-02
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-03-08
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2020-02-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-05-08
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3565	2024-03-20
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Orthopedic	Class 2	888.3560	2024-03-20
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2024-03-20
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2019-07-06
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2020-02-26
HFS	Shield, Nipple	General Hospital	Class 1	880.5630	2022-06-14

Official Correspondent

Marinela Cebic

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SteriPack USA (Limited) LLC

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
K121249	Paramed S.R.L.	MULTIARRAY KIT	2012-06-12
K000935	Mri Devices Corp.	KFA-63 KNEE AND FOOT ARRAY	2000-04-07
K102889	Hitachi Medical Systems America, Inc.	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	2010-12-20
K110373	Esaote, S.p.A.	TEMPOROMANIBULAR COIL 15	2011-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009656988. Last updated year: 2026. Please use registration number 3009656988 when referencing this establishment in official correspondence.