Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1647149

FEI Number

1000306139

Entity Name

Steritec Services, LLC

City/State/Country

ATHENS, TX, US

Establishment Address

1705 ENTERPRISE ST., ATHENS, TX 75751, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Steritec Services LLC (Owner Number: 10091079)

Owner / Operator Contact Address

1705 Enterprise St, Athens, TX 75751, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

dental bone plate cascade catheter endoscopic injection needle Cagent lavage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-04-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-07-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-06-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-08-07
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2024-07-09
FCZ	Tube, Smoke Removal, Endoscopic	Gastroenterology, Urology	Class 1	876.1500	2024-08-07
HWD	Starter, Bone Screw	Orthopedic	Class 1	888.4540	2024-07-09
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2024-06-28
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2024-06-27
JEY	Plate, Bone	Dental	Class 2	872.4760	2024-06-27
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-07-10
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-04-16
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2024-08-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-07-09
FCM	Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	Gastroenterology, Urology	Class 2	876.5130	2024-07-09
KOD	Catheter, Urological	Gastroenterology, Urology	Class 2	876.5130	2024-07-09
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2024-12-16
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	2024-06-27
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-12-16
FOS	Catheter, Umbilical Artery	General Hospital	Class 2	880.5200	2024-07-09
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2024-08-07
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2024-08-07
LJE	Catheter, Nephrostomy	Unknown	Class U	N/A	2024-08-07
KMF	Bandage, Liquid	General Hospital	Class 1	880.5090	2024-07-09
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-07-09
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-07-09
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2024-12-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-07-09
JEY	Plate, Bone	Dental	Class 2	872.4760	2024-07-09
LNM	Agent, Bulking, Injectable For Gastro-Urology Use	Unknown	Class 3	N/A	2024-07-09
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2024-07-09
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-06-28
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-06-28
FOS	Catheter, Umbilical Artery	General Hospital	Class 2	880.5200	2024-07-09
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-07-09
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-07-09
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-07-09
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2024-08-07
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2026-01-20
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2024-06-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2024-06-28
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2024-08-07
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-07-10
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2024-08-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-07-09
KOE	Dilator, Urethral	Gastroenterology, Urology	Class 2	876.5520	2024-12-16
EZN	Dilator, Catheter, Ureteral	Gastroenterology, Urology	Class 2	876.5470	2024-12-16
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2024-07-09
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2024-06-26
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2024-07-09
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2024-08-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-07-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-07-10
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2024-08-07
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2024-07-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-06-27
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2024-06-27

Official Correspondent

Heidi Roberts

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Steritec Services 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
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Z-0024-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4720

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1647149. Last updated year: 2026. Please use registration number 1647149 when referencing this establishment in official correspondence.