Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1123010

FEI Number

1000123297

Entity Name

TRINITY STERILE, INC.

City/State/Country

SALISBURY, MD, US

Establishment Address

201 Kiley Dr, SALISBURY, MD 21801, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

TRINITY STERILE, INC. (Owner Number: 9003800)

Owner / Operator Contact Address

201 KILEY DR., --, Salisbury, MD 21801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aspirator Suture Removal Kit Forceps Ear Forceps Kit Kit Spatula Minor Laceration Tray Pessary Fox Eye Shield Disposable Underpad Elevator Mogen Clamp Hemorrhoidal Ligator Bite Block Tray Staple Remover Wire Knot Tightener Phlebotomy Kit Kit Dressing Change Tray Uterine Sound Kit Urethral Sound Bone File Port Access Tray Dressing Tray Obstetrical Forceps Scalpel Handle Kit Scalpel Blade Joint Aspiration Tray Gigli Saw Micro Ear Hook Vaginal Speculum - Metal Explorer Wound Care Kit Laryngeal Mirror Comedone Extractor Foreign Body Instrument Kit Bandage Plier Kit Forceps Scissors Infrared Thermometer Trach Care Kit Vaginal Speculum - Non-Metal Retractor Curette Face Mask Kit Kit Rectal Speculum Kit Ring Cutter Disposable Ear Curette Brushes Tape Kit Traction Bow Lachrymal Probe Needle Holder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2024-06-25
MCZ	Suture Removal Kit	General, Plastic Surgery	Class 1	878.4800	2019-08-22
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-05-05
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2024-05-13
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-12-21
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	1996-07-03
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2024-05-13
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-08-10
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2024-05-16
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-05-13
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2024-12-24
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2024-06-25
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2024-05-16
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	Class 2	876.4400	2024-05-16
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2020-05-28
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-12-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-05-13
OFM	Phlebotomy Blood Collection Kit	Cardiovascular	Class 2	870.2750	2020-05-28
FCH	Tray, Biopsy, Without Biopsy Instruments	Gastroenterology, Urology	Class 1	876.4730	2012-12-20
OXQ	Dressing Change Tray	General Hospital	Class 1	880.5075	2021-03-09
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2024-05-16
FCN	Urinary Drainage Collection Kit, For Indwelling Catheter	Gastroenterology, Urology	Class 2	876.5250	1996-07-03
FBX	Sound, Urethral, Metal Or Plastic	Gastroenterology, Urology	Class 1	876.5520	2024-05-16
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2024-05-13
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-08-09
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-08-09
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2024-05-16
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-05-10
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	1992-07-14
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2024-05-10
JYC	Cannula, Ear	General, Plastic Surgery	Class 1	878.4800	2017-01-19
OJT	Aspiration Tray	General, Plastic Surgery	Class 1	878.4800	2020-05-28
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2024-05-13
JYL	Hook, Microsurgical Ear	Ear, Nose, Throat	Class 1	874.4420	2024-05-13
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2023-05-05
EKB	Explorer, Operative	Dental	Class 1	872.4565	2024-06-25
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2016-08-10
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2024-05-16
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2024-05-10
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2024-05-13
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	1992-12-09
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	1992-07-14
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2024-06-25
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1992-07-14
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2024-05-13
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-05-09
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-27
NXA	Tracheotomy Care Kit	Anesthesiology	Class 2	868.5800	2020-05-28
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2020-03-02
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2024-05-13
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2013-02-25
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-06-15
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-08-20
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2012-01-26
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2024-05-16
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	1992-06-05
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2024-05-10
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	2024-05-16
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2024-05-10
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-05-28
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-05-13
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2024-05-13
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2022-09-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TRINITY STERILE, INC.

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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K914369	Deroyal Industries, Inc.	QUALTEX MAGNETIC INSTRUMENT DRAPE	1991-12-02
K812809	Abco Dealers, Inc.	STERILE ADHERENT DRAPES	1981-11-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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3007284437	ORTHO ARCH COMPANY INC	Schaumburg, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1123010. Last updated year: 2026. Please use registration number 1123010 when referencing this establishment in official correspondence.