STERIPACK USA (LIMITED) LLC

Contract manufacturer · Lakeland, FL

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2017Product codes first listed, by year (tallest: 8)2026

FDA registration: 3009656988 (openFDA record; or search FDA's registration database)
FEI number: 3009656988
Registered for: FDA registration year 2026
Establishment types: Manufacturer for export only; Manufacturer; Contract manufacturer
Owner or operator: SteriPack USA (Limited) LLC (FDA owner/operator no. 10044297)
Registered address: 4255 S Pipkin Rd, Lakeland, FL 33811
Contract listings: 32 device listings, 27 product codes, first listed Feb 10, 2017
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
FCW	Light Source, Fiberoptic, Routine	Class II	Gastroenterology and urology	Contract manufacturing	May 7, 2019
FMF	Syringe, Piston	Class II	General hospital	Contract manufacturing	Apr 8, 2021
FPA	Set, Administration, Intravascular	Class II	General hospital	Contract manufacturing	Jun 26, 2019
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	May 13, 2018
FZZ	Marker, Skin	Class I	General and plastic surgery	Contract manufacturing	Oct 29, 2020
GDF	Guide, Needle, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jul 2, 2019
GXY	Electrode, Cutaneous	Class II	Neurology	Contract manufacturing	Feb 25, 2020
HFS	Shield, Nipple	Class I	General hospital	Contract manufacturing	Jun 14, 2022
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Mar 20, 2024
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Mar 20, 2024
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Mar 20, 2024
ITX	Transducer, Ultrasonic, Diagnostic	Class II	Radiology	Contract manufacturing	May 8, 2026
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Class II	Radiology	Contract manufacturing	Mar 8, 2019
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Mar 20, 2024
KGN	Wound Dressing With Animal-Derived Material(S)	Unclassified	General and plastic surgery	Contract manufacturing	Feb 25, 2020
KNW	Instrument, Biopsy	Class II	Gastroenterology and urology	Contract manufacturing	May 14, 2018
LLZ	System, Image Processing, Radiological	Class II	Radiology	Contract manufacturing	Mar 8, 2019
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Mar 20, 2024
MIG	Strip, Test Isoniazid	Unclassified	Clinical toxicology	Contract manufacturing	Jul 19, 2019
MOS	Coil, Magnetic Resonance, Specialty	Class II	Radiology	Contract manufacturing	May 14, 2018
MPN	Tissue Adhesive For The Topical Approximation Of Skin	Class II	General and plastic surgery	Contract manufacturing	Feb 10, 2017
NEU	Marker, Radiographic, Implantable	Class II	General and plastic surgery	Contract manufacturing	Jul 2, 2019
NNI	Container, Specimen, Non-Sterile	Class I	Pathology	Contract manufacturing	Feb 18, 2022
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Class I	Pathology	Contract manufacturing	Dec 28, 2020
NZU	Collector, Urine, Powered, Non Indwelling Catheter	Class I	Gastroenterology and urology	Contract manufacturing	Nov 23, 2021
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class II	Orthopedic	Contract manufacturing	Mar 20, 2024
OMP	Negative Pressure Wound Therapy Powered Suction Pump	Class II	General and plastic surgery	Contract manufacturing	Jun 26, 2019